This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

86545 

Vol. 88, No. 239 

Thursday, December 14, 2023 

1Public Health Service Act, 42 U.S.C. 247d § 319 

(2003). https://www.govinfo.gov/content/pkg/ 

USCODE-2019-title42/pdf/USCODE-2019-title42- 

chap6A-subchapII-partB-sec247d.pdf. 

2Robert T. Stafford Disaster Relief and Emergency 

Assistance Act, 42 U.S.C. 5121 et seq. § 102 (1988). 

https://www.fema.gov/sites/default/files/ 

documents/fema_stafford_act_2021_vol1.pdf. 

3FEMA, ‘‘Disaster Declaration Process,’’ May 

2011. Available online at: https://www.fema.gov/ 

pdf/media/factsheets/dad_disaster_declaration.pdf. 

DEPARTMENT OF AGRICULTURE 

Food and Nutrition Service 

7 CFR Part 246 

[FNS–2023–0027] 

RIN 0584–AE94 

Special Supplemental Nutrition 

Program for Women, Infants, and 

Children (WIC): Implementation of the 

Access to Baby Formula Act of 2022 

and Related Provisions 

AGENCY: Food and Nutrition Service 

(FNS), U.S Department of Agriculture 

(USDA). 

ACTION: Final rule with request for 

comment. 

SUMMARY: This rulemaking serves to 

amend the Special Supplemental 

Nutrition Program for Women, Infants, 

and Children (WIC) Program regulations 

by incorporating provisions of the 

Access to Baby Formula Act of 2022 and 

making related amendments. ABFA 

establishes waiver authority for the 

Secretary of Agriculture to address 

certain emergencies, disasters, and 

supply chain disruptions impacting 

WIC, and adds requirements to State 

agency infant formula cost containment 

contracts to protect against disruptions 

to the Program in the event of a recall. 

The provisions focus on improving State 

agencies’ ability to ensure continuity of 

Program operations during emergency 

periods (i.e., emergencies, disasters, and 

public health emergencies) and supply 

chain disruptions, while ensuring 

access to Program benefits among lowincome pregnant and postpartum 

participants, infants, and children up to 

5 years of age who are at nutritional 

risk. 

DATES: This rule is effective February 

12, 2024. Written comments must be 

received on or before February 12, 2024 

to be assured of consideration. Online 

comments submitted through the 

Federal eRulemaking Portal on this rule 

must be received on or before February 

12, 2024. 

ADDRESSES: The Food and Nutrition 

Service, USDA, invites interested 

persons to submit written comments on 

this final rule. USDA seeks comment on 

all aspects of this rule. Comments may 

be submitted in writing by one of the 

following methods: 

• Federal eRulemaking Portal: Go to

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

• Regular U.S. Mail: WIC

Administration, Benefits, and 

Certification Branch, Policy Division, 

Food and Nutrition Service, P.O. Box 

2885, Fairfax, Virginia 22031–0885. 

• Overnight, Courier, or Hand

Delivery: Allison Post, WIC 

Administration, Benefits, and 

Certification Branch, Policy Division, 

Food and Nutrition Service, 1320 

Braddock Place, 3rd Floor, Alexandria, 

Virginia 22314. 

• All written comments submitted in

response to this final rule will be 

included in the record and will be made 

available to the public. Please be 

advised that the substance of the 

comments and the identity of the 

individuals or entities submitting the 

comments will be subject to public 

disclosure. FNS will make the written 

comments publicly available on the 

internet via http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Allison Post, Chief, WIC 

Administration, Benefits, and 

Certification Branch, Policy Division, 

Supplemental Nutrition and Safety 

Programs, Food and Nutrition Service, 

USDA, 1320 Braddock Place, 

Alexandria, Virginia, (703) 457–7708 or 

Allison.Post@usda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Overview

On May 21, 2022, the President

signed the Access to Baby Formula Act 

of 2022 (ABFA, Pub. L. 117–129) into 

law. ABFA amends Section 17 of the 

Child Nutrition Act of 1966 (CNA, 42 

U.S.C. 1786) to (1) establish permanent 

waiver authority to the Secretary of 

Agriculture to address certain 

emergencies, disasters, and supply 

chain disruptions impacting WIC; and 

(2) require WIC State agency infant

formula cost containment contracts to

include specific remedies to protect

against disruptions to the Program in

the event of an infant formula recall. 

This rule amends 7 CFR part 246 to 

codify the provisions of ABFA and 

implement related changes which will 

strengthen WIC’s ability to address 

emergency periods and supply chain 

disruptions, particularly those 

impacting infant formula. For the 

purpose of this rule: 

• emergency periods are defined as a

public health emergency declared by the 

Secretary of Health and Human Services 

and any renewal of such a public health 

emergency; a presidentially declared 

major disaster; or a presidentially 

declared emergency, in alignment with 

the definition set forth in ABFA.1 2

• supply chain disruption is defined

as a shortage of WIC supplemental 

foods, including infant formula, that 

limits WIC participants’ ability to 

reasonably purchase WIC supplemental 

foods benefits within a State agency’s 

jurisdiction, as determined, and 

declared by the Secretary, in alignment 

with the definition set forth in ABFA.3

Specifically, this rulemaking will: 

(1) Codify permanent, expanded

waiver authority of the Secretary to help 

ensure continuity of WIC services 

during emergency periods and supply 

chain disruptions impacting WIC. 

(2) Codify requirements for WIC State

agencies to include language in their 

WIC infant formula cost containment 

contracts that describes remedies in the 

event of an infant formula recall, 

including how an infant formula 

manufacturer would protect against 

disruption to supplemental food access 

by WIC participants. 

(3) Add a new provision that WIC

State agencies must include as a part of 

the State Plan a ‘‘plan of alternate 

operating procedures’’ in the event of an 

emergency period, supplemental food 

recall, or other supply chain disruption. 

In the development of this rule, the 

Department prioritized equity, access, 

and nutrition security for WIC 


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4U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘Food and Nutrition Security.’’ 

Available online at: https://www.usda.gov/ 

nutrition-security#:∼:text=Nutrition%20

security%20means%20consistent%20access,

Tribal%20communities%20and%20Insular

%20areas. 

5Administrative Procedure Act, 5 U.S.C. 553 

(1966). https://uscode.house.gov/view.xhtml?

req=granuleid:U.S.C.-prelim-title5- 

section553&num=0&edition=prelim. 

6FEMA, ‘‘COVID–19 Disaster Declarations,’’ 

August 20, 2021. Available online at: https://

www.fema.gov/covid-19. 

7FEMA, ‘‘FEMA Assistance for Tribal 

Governments,’’ March 17, 2021. Available online at: 

https://www.fema.gov/fact-sheet/fema-assistancetribal-governments#:∼:text=

Tribes%20that%20are%20Recipients

%20will%20have%20a%20direct,in%20

the%20Tribal%20Declarations%20

Pilot%20Guidance.%20More%20items. 

applicants and participants.4 The 

Department also recognizes that the rule 

may impact WIC State agencies, 

including Indian Tribal Organizations 

(ITOs), local agencies, clinics, and WICauthorized vendors. Additionally, the 

Department recognizes that the rule may 

impact infant formula manufacturers. 

While WIC is not designed to be a 

disaster assistance program, this rule 

aims to improve the continuity of 

services and Program benefits and 

access to supplemental foods for 

participants during these unforeseen 

circumstances. Relatedly, customer 

service, participation, and retention, as 

well as program integrity, have also 

been considered in this rulemaking. To 

support WIC State agencies in equitable 

implementation of this rulemaking, FNS 

plans to provide WIC State agencies 

with technical assistance, which may 

include guidance documents, 

memoranda, webinars, and/or 

presentations at conferences. In 

addition, FNS will explore ways to 

support WIC State agencies in providing 

alternative languages and formats and 

effective communication of program 

changes, including with auxiliary aids 

and services to participants and 

vendors. 

Given the need for swift 

implementation of ABFA following 

recent disruptions to the supply chain 

and wide-ranging effects of the infant 

formula recall, this is a final rule with 

request for comments pursuant to the 

Administrative Procedure Act’s 

exemption on matters relating to agency 

management or personnel or to public 

property, loans, grants, benefits, or 

contracts.5 It is imperative the 

provisions are implemented as soon as 

is feasible so that FNS and WIC State 

agencies have mechanisms in place to 

ensure continuity of operations and 

access to Program benefits for WIC 

participants. The Department has 

requested comments on specific topics 

in this rule that can inform future 

rulemaking, policy, and/or guidance 

related to infant formula and will 

consider comments on all aspects of the 

rule when developing guidance and 

policy. Given the prescriptive nature of 

ABFA and the need for swift 

implementation ultimately in the 

interest of WIC participants, the 

Department believes this approach best 

serves the public interest. The 

Department has collected, and will 

consider, input from stakeholders to 

ensure the implementation of this rule 

supports the WIC population and 

achieves the intended results. For 

example, FNS Regional Operations and 

Support has collected feedback on FNS’ 

response to the infant formula recall and 

the Coronavirus Disease 2019 (COVID– 

19) public health emergency from FNS

Regional Offices and WIC State

agencies. FNS has considered this

feedback in development of this rule

and will continue to do so when

developing guidance and policy to

support the successful implementation

of the rule. The Department recognizes

the value of stakeholder feedback and

will continue to seek and collect

feedback to inform future technical

assistance.

II. Background

A. Overview of WIC

WIC is currently administered by 89

WIC State agencies, including the 50 

geographic states, the District of 

Columbia, 33 Indian Tribal 

Organizations (ITOs), and five U.S. 

Territories (the Commonwealth of the 

Northern Mariana Islands, American 

Samoa, Guam, Puerto Rico, and the U.S. 

Virgin Islands). By providing 

supplemental foods, nutrition 

education, including breastfeeding 

promotion and support, and referrals to 

health and other social services, WIC 

addresses the nutritional needs and 

safeguards the health of low-income 

pregnant and postpartum participants, 

infants, and children up to 5 years of 

age who are at nutritional risk. 

According to their participant 

category and nutritional needs, WIC 

participants receive supplemental foods 

on a monthly basis from one of seven 

evidence-based food packages. The 

amounts and categories of foods 

provided are intended to supplement 

participants’ diets and provide specific 

nutrients known to be lacking in the 

diets of WIC’s target population. 

WIC participants typically access 

supplemental foods, including infant 

formula, through a retail food delivery 

system. In such systems, a WIC shopper 

goes to a WIC-authorized vendor (i.e., a 

retail store authorized by the State 

agency), selects foods available in their 

benefit balance, and uses a food 

instrument, typically an Electronic 

Benefits Transfer (EBT) card, to 

purchase the items. Outside of a retail 

food delivery system, some WIC 

participants access their supplemental 

foods through a home food delivery or 

direct distribution system operated by 

the WIC State agency. Additionally, 

WIC participants with certain medical 

conditions who require exempt 

formulas or WIC-eligible nutritionals 

may receive these as part of, or in 

addition to, their WIC food package 

with appropriate documentation. These 

exempt formulas and WIC-eligible 

nutritionals are procured outside of the 

traditional WIC State agency costcontainment contracting process for 

standard milk and soy-based infant 

formula and may be purchased at the 

store like their other WIC items, or 

through other systems set up by the WIC 

State agency, depending on availability 

and need for the product(s). 

B. WIC Program Waiver Authority

Historically, WIC has had limited

authority to waive Program 

requirements. However, since the onset 

of the COVID–19 public health 

emergency, WIC has experienced a 

series of disruptions to Program 

operations necessitating the ability for 

USDA’s Food and Nutrition Service 

(FNS) to have permanent waiver 

authority. 

On February 17, 2022, a major infant 

formula manufacturer voluntarily 

recalled certain powder infant formula, 

including exempt infant formula. While 

recalls may be conducted because a 

mandatory order has been issued by the 

U.S. Food and Drug Administration 

(FDA) under statutory authority, they 

can also be conducted voluntarily by a 

manufacturer, as in this case. This recall 

exacerbated existing supply chain issues 

resulting from the ongoing COVID–19 

public health emergency. During its 

early response to the shortage, FNS used 

waiver authority granted under Section 

301 of the Robert T. Stafford Disaster 

Relief and Emergency Assistance Act, 

(‘‘Stafford Act,’’ 42 U.S.C. 5121), to 

approve several waiver types for WIC 

State agencies to help WIC participants 

obtain infant formula. This was possible 

because of existing COVID–19 major 

disaster declarations covering the 

geographic areas of all WIC State 

agencies, including States, ITOs, and 

Territories.6 7

Section 301 of the Stafford Act 

provides any Federal agency charged 

with the administration of a federal 


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8U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum 

#2021–10: Updated Expiration Schedule for 

Existing FNS-Approved WIC COVID–19 Waivers,’’ 

September 20, 2021. Available online at: https://

www.fns.usda.gov/wic/policy-memorandum-2021- 

10. 

9U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum 

#2022–6: Implementation of the Access to Baby 

Formula Act of 2022 Public Law 117–129,’’ June 6, 

2022. Available online at: https://

www.fns.usda.gov/wic/implementation-accessbaby-formula-act-2022. 

10U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum 

#2023–1: Abbott Infant Formula Recall Waiver 

Expiration Schedules,’’ November 8, 2022. 

Available online at: https://www.fns.usda.gov/ 

resource/abbott-infant-formula-recall-waiverexpiration-memo#. 

11U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum 

#2022–6: Implementation of the Access to Baby 

Formula Act of 2022 Public Law 117–129,’’ June 6, 

2022. Available online at: https://

www.fns.usda.gov/wic/implementation-accessbaby-formula-act-2022. 

12U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum 

#2023–3: Unwinding Infant Formula Flexibilities in 

WIC,’’ February 1, 2023. Available online at: https:// 

www.fns.usda.gov/wic/policy-memorandum-2023- 

3-unwinding-infant-formula-flexibilities. 

assistance program with the authority to 

modify or waive administrative 

conditions for assistance that would 

otherwise prevent the giving of 

assistance if the inability to meet such 

conditions is a result of the major 

disaster. Activation of Section 301 of the 

Stafford Act requires a State Governor’s 

request and the President’s approval. 

When approved, these are referred to as 

Major Disaster Declarations. Section 301 

of the Stafford Act cannot be activated 

by emergency declarations, public 

health emergencies, or supply chain 

disruptions. Prior to March 2020, 

Section 301 of the Stafford Act was the 

only waiver authority available to grant 

administrative flexibilities in WIC. 

On March 13, 2020, the ongoing 

COVID–19 crisis was declared a public 

health emergency of sufficient severity 

and magnitude to warrant declaration of 

a nationwide public health emergency 

through the Secretary of Health and 

Human Services. Over the next several 

weeks, in response to the COVID–19 

public health emergency, major disaster 

declarations were put into place 

covering all WIC State agencies, 

including States, Indian Tribal 

Organizations, and U.S. Territories, 

pursuant to Section 501(b) of the 

Stafford Act. While the major disaster 

declarations would eventually enable 

WIC State agencies to request regulatory 

waivers under the Stafford Act’s 

authority, immediate and additional 

flexibilities were necessary to support 

WIC State agencies. 

Therefore, on March 18, 2020, the 

Families First Coronavirus Response 

Act (FFCRA, Pub. L. 116–127) was 

signed into law to assist with the 

COVID–19 public health emergency. 

USDA received temporary authority to 

provide WIC State agencies with 

flexibilities necessary to continue 

operations and safely provide Program 

benefits to participants. Specifically, 

Section 2203 of FFCRA provided USDA 

with the statutory waiver authority 

necessary to waive the physical 

presence requirement for all applicants 

and participants seeking certification or 

recertification in WIC; and defer 

anthropometric (i.e., height/length and 

weight) and bloodwork requirements 

which are used to determine nutritional 

risk. As a result, FNS waived the 

statutory requirement for in-person WIC 

clinic visits, thereby encouraging social 

distancing, during the COVID–19 public 

health emergency. Under Section 2204 

of FFCRA, WIC State agencies could 

also request USDA to waive or modify 

WIC regulations. Such requests could 

only be granted if the WIC State agency 

(1) could not meet regular Program 

requirements due to COVID–19, and (2) 

such waiver or modification was 

necessary to provide assistance to WIC 

participants. As prescribed in FFCRA, 

the Department had the authority to 

provide waivers through September 30, 

2020, which was then extended through 

September 30, 2021, through the 

Continuing Appropriations Act, 2021 

and Other Extensions Act (Pub. L. 116– 

159). Certain WIC waivers granted prior 

to September 30, 2021, were then 

extended through FNS’ policy guidance 

until 90 days after the end of the 

nationally declared public health 

emergency under Section 319 of the 

Public Health Service Act,8 which 

ended on May 11, 2023, per 

announcement from the U.S. 

Department of Health and Human 

Services (HHS). FFCRA provided USDA 

with the necessary authority to provide 

WIC State agencies with the flexibility 

to pivot operations and continue serving 

Program participants during a public 

health emergency. However, USDA’s 

authority was temporary and designed 

to specifically address COVID–19. 

While the existing COVID–19 major 

disaster declarations and resulting 

Stafford Act authority provided a 

vehicle through which FNS could grant 

WIC State agencies waivers, under 

normal circumstances, such waiver 

authority would not typically be 

available for the Department to respond 

to an infant formula recall, nor could 

the Department issue nationwide 

waivers. As a result, in direct response 

to the infant formula recall, Congress 

recognized the need to provide USDA 

with permanent authority to waive or 

modify certain statutory and regulatory 

requirements when certain conditions 

are present. 

ABFA amended Section 17 of the 

CNA (42 U.S.C. 1786) to (1) establish 

waiver authority for the Secretary of 

Agriculture to address certain 

emergencies, disasters, and supply 

chain disruptions impacting WIC; and 

(2) require WIC State agency infant 

formula cost containment contracts to 

include specific remedies to protect 

against disruptions to the Program in 

the event of a recall. Unlike the Stafford 

Act, ABFA provides USDA with the 

authority to issue waivers for one or 

more State agencies, including 

nationwide, and does not require that 

each State agency individually request 

specific waivers. As a result of ABFA, 

FNS issued an implementing policy 

memorandum describing the infant 

formula cost containment contract 

requirements and waiver authority.9 In 

order to provide WIC State agencies 

with additional notice in anticipation of 

the expiration of the major disaster 

declarations in affected areas which 

formally ended May 11, 2023, FNS 

transferred waivers originally approved 

under the Stafford Act and the existing 

COVID–19 major disaster declaration for 

the affected area to approval under the 

waiver authority granted by ABFA and 

the existing COVID–19 major disaster 

declaration for the affected area. 

Accordingly, to aid WIC participants in 

purchasing infant formula using WIC 

benefits, FNS extended waivers set to 

expire under the ABFA authority and 

established a new expiration date for 

most waivers granted in response to the 

infant formula recall through the earlier 

of either January 31, 2023, or 60 days 

after the expiration of the COVID–19 

major disaster declaration in the 

affected area.10 This revised expiration 

schedule applied to most waiver types, 

including those related to medical 

documentation, maximum monthly 

allowances of infant formula, imported 

formula authorization and issuance, and 

vendor substitutions.11 This expiration 

date was again extended on December 

19, 2022, in a letter sent to WIC State 

agencies and formally implemented 

through FNS Policy Memorandum 

#2023–3: Unwinding Formula 

Flexibilities in WIC on February 2, 2023. 

FNS communicated that revised 

expiration dates for the formula waivers 

included rolling extensions for various 

waivers through June 30, 2023, based on 

the continued need for flexibility by the 

WIC State agencies.12


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13U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘Guide to Coordinating Special 

Supplemental Nutrition Program for Women, 

Infants, and Children (WIC) Services When Regular 

Operations Are Disrupted,’’ January 18, 2022. 

Available online at: https://www.fns.usda.gov/wic/ 

guide-coordinating-wic-service-during-disasters. 

14U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum #96– 

6: WIC Infant Formula Rebate Reviews,’’ March 12, 

1996. Available online at: https://www.fns.

usda.gov/wic/infant-formula-rebate-reviews. 

15U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum 

#2004–4: Implementation of the Infant Formula 

Cost Containment Provisions of P.L.aw 108–265,’’ 

July 30, 2004. Available online at: https://www.fns.

usda.gov/wic/implementation-infant-formula-costcontainment-provisions-pl-108-265#:∼:

text=This%20memorandum%20provides%20

guidance%20on%20the%20implementation%20of,

2004%2C%20%28Reauthorization%20

Act%29%20enacted%20on%20June%2030

%2C%202004. 

C. WIC Disaster Planning

WIC State agencies are required to

submit an annual plan for Program 

operations. Program regulations at 7 

CFR 246.4 define State Plan 

requirements, but plans to address 

potential emergencies, disasters, or 

significant disruptions in operations are 

not currently one of the required 

elements. Nearly all State agencies 

already voluntarily maintain a disaster 

plan; however, these plans are typically 

part of a broader health department or 

other State agency disaster plan and do 

not address WIC-specific Program 

operations during emergencies nor do 

they typically address other operational 

disruptions beyond natural disasters. 

FNS provides information to help 

WIC State agencies plan for meeting the 

needs of WIC participants and 

applicants prior to and during a disaster 

response; plan for continued WIC 

benefits during public health 

emergencies; and plan for other 

situations that disrupt regular WIC 

operations through the guidance 

document, Guide to Coordinating 

Special Supplemental Nutrition 

Program for Women, Infants, and 

Children (WIC) Services When Regular 

Operations Are Disrupted.13 This 

guidance highlights operational 

flexibilities in WIC regulations that WIC 

State agencies may implement quickly. 

The COVID–19 public health emergency 

and the infant formula recall 

highlighted the need for all State 

agencies to have formal contingency 

plans in place to ensure the continuity 

of WIC operations during emergency 

periods (i.e., emergencies, disasters, and 

public health emergencies) and supply 

chain disruptions, while ensuring 

access to Program benefits among lowincome pregnant and postpartum 

participants. 

D. Infant Formula Cost Containment

Historical Background

In the 1980s WIC State agencies 

became increasingly interested in cost 

containment initiatives due to rising 

food costs and their potential to limit 

Program participation due to 

insufficient funding. Infant formula 

represented a significant portion of WIC 

food costs so there was specific interest 

in infant formula cost containment 

contracts. Early initiatives by some State 

agencies were so successful that in 

1989, the Agriculture Appropriations 

Act of 1989 (Pub. L. 100–460) directed 

all WIC State agencies to explore the 

feasibility of cost-containment measures 

and implement such a measure if found 

to be viable. Although the provisions of 

the Agriculture Appropriations Act of 

1989 expired on September 30, 1989, 

the Child Nutrition and WIC 

Reauthorization Act of 1989 (Pub. L. 

101–147) extended these provisions and 

required the Secretary to prescribe 

regulations to carry out these 

provisions. The Child Nutrition and 

WIC Reauthorization Act of 1989 also 

outlined exceptions to these provisions, 

notably for ITOs that operate their own 

WIC Program and serve less than 1,000 

participants. 

The WIC Infant Formula Procurement 

Act of 1992 (Pub. L. 102–512) amended 

the CNA to enhance competition among 

infant formula manufacturers and 

reduce the per unit costs of infant 

formula purchased by WIC. In 1996, 

FNS issued WIC Policy Memorandum 

#96–6: WIC Infant Formula Rebate 

Reviews, which provides guidance to 

avoid rebate billing discrepancies and 

can serve as a WIC State agency 

reference during the procurement and 

contracting process.14 Congress also 

amended the CNA through the Child 

Nutrition and WIC Reauthorization Act 

of 2004 (Pub. L. 108–265) to include 

additional technical definitions that 

further clarified how cost containment 

systems must be structured. FNS 

established regulations to implement 

each of these laws and released WIC 

Policy Memorandum #2004–4: 

Implementation of the Infant Formula 

Cost Containment Provisions of P.L. 

108–265 to address Public Law 108– 

265.15

During the onset of the nationwide 

infant formula shortage and prior to the 

passage of ABFA, there were no federal 

requirements for infant formula rebate 

contracts to include remedies in the 

event of a recall. FNS used its limited 

waiver authority under the Stafford Act 

to issue waivers to allow WIC State 

agencies to exceed the maximum 

monthly allowance for infant formula 

and exempt infant formula and issue 

non-contract brand formula without 

medical documentation (except in Food 

Package III). Each WIC State agency had 

to come to an agreement with the 

manufacturer holding their rebate 

contract on Program flexibilities 

allowed under these waivers to protect 

against disruption to Program 

participants. Additionally, the infant 

formula manufacturer whose product 

was the subject of the voluntary recall 

voluntarily paid rebates on competitive, 

non-contract brand infant formula in 

WIC State agencies where they held the 

contract. 

E. Infant Formula Cost Containment

Contracts

The Child Nutrition Act of 1966, 

(CNA, 42 U.S.C. 1786(h)(8)(A)(i)(I)) and 

WIC Program regulations at 7 CFR 

246.16a require most WIC State agencies 

to continuously operate a cost 

containment system for infant formula. 

WIC State agencies have historically met 

this requirement through a competitive 

bidding process that requires sealed 

bids, for single-supplier rebate 

contracts. WIC State agencies solicit 

sealed bids and award a contract to the 

manufacturer offering the lowest price. 

Contracted manufacturers provide a 

rebate on each can of their infant 

formula purchased by Program 

participants through authorized WIC 

vendors. The WIC State agency invoices 

the manufacturer for payment directly 

to the WIC State agency, which does not 

impact the payments to retail stores who 

accept WIC transactions. The resulting 

rebate payments from manufacturers are 

used to offset WIC food costs, allowing 

WIC State agencies to serve more WIC 

participants. Each WIC State agency or 

alliance of State agencies that solicits for 

a rebate contract manages their own 

procurement and contracting process 

through execution and implementation. 

WIC State agencies may implement an 

alternative cost containment system; 

however, the system must provide a 

savings equal to or greater than a singlesupplier competitive system through the 

process described in WIC regulations at 

7 CFR 246.16a(d). To date, WIC State 

agencies have not implemented any 

alternative cost containment systems. 

Once a contract is executed and 

implemented, the contract brand milk 

and soy-based formulas are added to the 

WIC State agency’s Approved Product 

List (APL) and are made available for 

issuance and redemption throughout the 

State agency’s WIC Program. A 

competent professional authority (CPA) 

in the WIC clinic setting is responsible 

for completing a nutrition assessment 

for WIC participants, and then 


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prescribing and individually tailoring 

an appropriate food package. The 

primary contract brand milk- or soybased infant formula is considered ‘‘first 

choice’’ and will be issued as the default 

in the food packages for infants who 

receive formula from WIC. Based on 

information from the participant, 

including cultural or dietary 

preferences, and/or nutrition assessment 

findings, an alternate formula, such as a 

soy-based option or another milk-based 

option, within the rebate contract (i.e., 

contract brand infant formula) may be 

deemed appropriate for issuance. 

Medical documentation is generally not 

required for milk- and soy-based 

contract brand infant formulas offered 

under the rebate contract. 

Infant formula rebate funds offset a 

significant amount of food costs. In 

fiscal year 2022, infant formula rebate 

amounts totaled approximately $1.5 

billion, the cost of providing benefits to 

an average of 1.32 million participants 

each month, or 21 percent of WIC 

participants monthly, as indicated by 

the WIC Financial Management and 

Participation Report (FNS–798). 

III. Discussion of Regulatory 

Amendments 

A. Add Waiver Authority Granted by the 

Access to Baby Formula Act 

1. Add New Definitions (§ 246.2) 

This rule adds definitions of 

Emergency period, Qualified 

administrative requirement, Recall, and 

Supply chain disruption consistent with 

ABFA statutory language. 

a. This rule defines an Emergency 

period as a period during which there 

exists: (1) a presidentially declared 

major disaster as defined under Section 

102 of the Robert T. Stafford Disaster 

Relief and Emergency Assistance Act 

(42 U.S.C. 5121 et seq.), (2) a 

presidentially declared emergency as 

defined under Section 102 of the Robert 

T. Stafford Disaster Relief and 

Emergency Assistance Act (42 U.S.C. 

5121 et seq.), (3) a public health 

emergency declared by the Secretary of 

Health and Human Services under 

Section 319 of the Public Health Service 

Act (42 U.S.C. 247d), or (4) a renewal of 

such a public health emergency 

pursuant to Section 319. This aligns 

with the definition provided by AFBA 

and does not include State-declared 

emergencies, disasters, or public health 

emergencies. 

b. This rule defines Qualified 

administrative requirement as (1) a 

statutory requirement under Section 17 

of the CNA (42 U.S.C. 1786), or (2) a 

regulatory requirement issued pursuant 

to this section. This aligns with the 

definition provided by ABFA and 

encompasses the scope of Program 

requirements that may be waived or 

modified by the Secretary. 

c. This rule defines Recall as it is 

defined in the U.S. Food and Drug 

Administration (FDA) regulations in 21 

CFR 7.3(g) or any successor regulation. 

FDA defines recall as a firm’s removal 

or correction of a marketed product that 

the FDA considers to be in violation of 

the laws it administers and against 

which the agency would initiate legal 

action (e.g., seizure). Recall does not 

include a market withdrawal, which is 

defined at 21 CFR 7.3(j) as a firm’s 

removal or correction of a distributed 

product which involves a minor 

violation that would not be subject to 

legal action by the FDA or which 

involves no violation (e.g., normal stock 

rotation practices, routine equipment 

adjustments and repairs, etc.) or a stock 

recovery, which is defined at 21 CFR 

7.3(k) as a firm’s removal or correction 

of a product that has not been marketed 

or that has not left the direct control of 

the firm (i.e., the product is located on 

premises owned by, or under the control 

of, the firm and no portion of the lot has 

been released for sale or use). The 

Department is committed to continued 

alignment with FDA’s definition of 

recall. Recalls may be conducted 

voluntarily by a manufacturer or may be 

required by FDA. 

d. This rule defines Supply chain 

disruption as a shortage of WIC 

supplemental foods that limits WIC 

participants’ ability to reasonably 

purchase supplemental foods using WIC 

benefits within a State agency’s 

jurisdiction, as determined, and 

declared by the Secretary for the 

purposes of WIC. This definition reflects 

ABFA statutory language and clarifies 

that supply chain disruption 

declarations as defined in this 

rulemaking are specifically for the 

purposes of WIC and do not impact or 

extend authority to other programs or 

entities. Supply chain disruptions can 

occur within any portion of a State 

agency’s jurisdiction, throughout the 

State agency’s jurisdiction, or within 

several State agencies’ jurisdictions, 

including nationwide. In accordance 

with ABFA, supply chain disruptions 

include those caused by recalls of WIC 

supplemental foods. Other causes of 

supply chain disruptions under ABFA 

may include but are not limited to, labor 

shortages, temporary business 

disruptions, delays in the availability of 

products across a wide range of 

industries, production issues, a 

mismatch between supply and demand 

or other shortages impacting WIC 

supplemental foods. The Department 

recognizes that unforeseen 

circumstances beyond those described 

may also cause a shortage of WIC 

supplemental foods that limits 

participants’ ability to purchase such 

foods using WIC benefits. However, not 

every potential cause described here, or 

potential unforeseen circumstance may 

impede the transaction and redemption 

of WIC benefits for supplemental foods. 

Therefore, the definition of supply 

chain disruption is not limited to any 

specific causes so that the Department 

maintains the flexibility to determine if 

a supply chain disruption has occurred 

and is able to respond to any future 

disruptions. 

2. Specify Criteria for Establishing 

Waivers and Timeframes for Use 

(§ 246.29) 

This rule creates a new provision at 

§ 246.29 that specifies the criteria under 

which a waiver or modification may be 

established, information WIC State 

agencies must provide to FNS when 

requesting a waiver, and the timeframes 

during which waivers will remain 

available for use by WIC State agencies. 

a. Requirements for Establishing a 

Waiver 

This rule provides a non-exhaustive 

list of conditions that must be met for 

the Secretary to waive a qualified 

administrative requirement for one or 

multiple WIC State agencies during an 

emergency period or supply chain 

disruption. In accordance with ABFA 

statutory provisions, a waiver may be 

established when the following criteria 

are met (1) the qualified administrative 

requirement cannot be implemented 

during any part of the emergency period 

or supply chain disruption, (2) the 

waiver is necessary to serve 

participants, and (3) the waiver does not 

substantially weaken the nutritional 

quality of supplemental foods. If the 

criteria are met, the Secretary may issue 

either nationwide waivers available for 

WIC State agencies to opt into, or State 

agency-specific waivers. 

The Department is including 

additional specifications in this 

rulemaking that the waiver or 

modification must: 

(1) Not materially impair any 

statutory or regulatory right of 

participants or potential participants as 

set forth at 7 CFR 246.8 and 7 CFR parts 

15, 15a and 15b which includes all 

protected classes for federally assisted 

programs in USDA; 

(2) Not present an unreasonable 

barrier to participation; 

(3) Not create new or additional 

eligibility requirements for 

participation; 


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(4) Comply with 7 CFR 246.13(b) to 

ensure State agencies maintain effective 

control over and accountability for all 

Program grants and funds; 

(5) Offer substitution options with 

similar nutritional quality, that most 

closely provide the maximum monthly 

allowance of supplemental foods, and 

that do not create new supplemental 

food categories as set forth in 7 CFR 

246.10(e)(12) Table 4; and 

(6) Meet additional requirements for 

the request and approval as determined 

necessary by FNS. 

Including these requirements is 

intended to provide WIC State agencies 

seeking waivers with basic parameters 

and to protect participants and 

applicants. While this rule will allow 

for more flexibilities in Program 

operations, the Department is 

committed to continued equity, access, 

and nutrition security for WIC 

applicants and participants and 

preventing unforeseen barriers to 

participation. Further, the Department is 

committed to clear and timely 

communication with State and local 

agency staff, WIC participants, and the 

public when an emergency period or 

supply chain disruption has been 

declared. 

b. Information Required From WIC State 

Agencies Requesting a Waiver 

ABFA laid out certain requirements 

that must be met for a waiver to be 

granted by FNS to a WIC State agency. 

A WIC State agency may request that a 

qualified administrative requirement be 

waived or modified through submission 

of a waiver request if the Secretary has 

not already issued an applicable 

nationwide waiver available for a WIC 

State agency to opt into. This rule 

establishes the minimum information a 

WIC State agency must provide to FNS 

when requesting a waiver to ensure that 

these criteria are met. Specifically, 

when submitting a request to FNS, WIC 

State agencies must provide: 

(i) The qualified administrative 

requirement the State agency is 

requesting to waive or modify 

(including the statutory or regulatory 

citation) and an explanation for why it 

cannot be met; 

(ii) Justification for why the waiver is 

necessary to continue WIC services; 

(iii) An explanation that the waiver 

meets the conditions set forth in new 

section 7 CFR 246.29(a); 

(iv) The emergency period or supply 

chain disruption under which the 

request is being made; and 

(v) The period for which the 

flexibility is being requested. 

The Department has deemed this the 

minimum information necessary to 

confirm the WIC State agency’s request 

meets the conditions required to waive 

or modify a qualified administrative 

requirement during an emergency 

period or supply chain disruption. 

However, contingent on the specific 

situation, FNS maintains the right to 

require additional information from a 

WIC State agency to support its waiver 

request. For example, a WIC State 

agency seeking a waiver or waiver 

extension may be required to provide 

justification, including, but not limited 

to, data to support the request, how the 

waiver will be implemented, estimated 

impact on WIC food funds for the time 

period being requested, or an 

explanation of how the WIC State 

agency will track or monitor the 

continued necessity for the waiver. The 

Department recognizes that each 

emergency period and supply chain 

disruption is unique and therefore State 

agencies may be asked to provide 

different types of information relevant 

to the specific scenario. Additional 

information regarding the waiver 

submission and review process will be 

provided through subsequent policy 

guidance. 

c. Duration of Waiver Availability 

This rule codifies the timeframes 

during which waivers can be available 

for use by WIC State agencies, as 

provided by ABFA. Waivers may be 

established at any time during an 

emergency period or supply chain 

disruption. 

A waiver established during an 

emergency period may be available for 

the duration of the emergency period 

and up to 60 days after the end of the 

emergency period. A waiver established 

during a declared supply chain 

disruption may be available for: 

(i) a period of up to 45 days from a 

date determined by the Secretary and 

renewed with at least 15 days’ notice 

provided by the Secretary, and 

(ii) no more than 60 days after the 

supply chain disruption declaration 

ceases to exist. 

In accordance with ABFA, if the 

Secretary determines that a supply 

chain disruption exists and issues a 

waiver, the Secretary will notify each 

State agency affected by the disruption. 

Likewise, the Secretary will notify each 

State agency affected by the disruption 

and granted a waiver as a result of the 

disruption at least 15 days prior to the 

end of the 45-day period if the supply 

chain disruption declaration has been 

renewed. FNS will communicate any 

supply chain disruption renewals as 

they occur and provide technical 

assistance on the process as needed. 

B. Update Requirements for State 

Agency Infant Formula Cost 

Containment Contracts 

1. Establish Minimum Required 

Remedies for Infant Formula Cost 

Containment Contracts (§ 246.16a) 

This rule establishes that a State 

agency must include remedies in the 

event of a recall in their infant formula 

cost containment contract to protect 

against disruption in infant formula 

supply to participants. In accordance 

with applicable Program requirements 

and the infant formula cost containment 

contract, the State agency will 

determine when remedies take effect 

and remain in effect. At minimum, the 

State agency’s infant formula cost 

containment contract must: 

(1) Allow infant formula to be issued 

in all unit sizes that may exceed the 

maximum monthly allowance. The State 

agency and contracted infant formula 

manufacturer must prioritize unit sizes 

that most closely provide the maximum 

monthly allowance; 

(2) Allow the issuance of non-contract 

brand formula without medical 

documentation (except in Food Package 

III); 

(3) When any contract brand infant 

formula of the contracted manufacturer 

is the subject of a recall, require the 

contracted manufacturer to: 

(i) Provide the State agency with an 

action plan, within a timeframe 

established within the contract, which 

includes supply data, to meet infant 

formula demand and limit disruption to 

Program participants in the affected 

jurisdiction(s) and 

(ii) Pay rebates on competitive, noncontract brand infant formula that meets 

the definition of infant formula at 7 CFR 

246.2. 

WIC State agencies may work with 

their legal counsel and procurement 

offices to include additional remedies 

beyond these regulatory minimum 

remedies in their infant formula 

contracts. WIC State agencies may also 

negotiate flexibilities that are within 

regulatory requirements and do not 

require Program waivers with their 

contracted infant formula 

manufacturers. 

As previously described, in response 

to the sustained nationwide infant 

formula shortage—resulting from the 

February 17, 2022, voluntary recall of a 

major source of powder infant formula, 

including exempt infant formula— 

which exacerbated existing COVID–19 

shortages, FNS used its limited waiver 

authority under the Stafford Act to issue 

waivers. This was possible because of 

existing COVID–19 major disaster 

declarations covering the geographic 


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Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 86551 

16U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum 

#2022–6: Implementation of the Access to Baby 

Formula Act of 2022 Pub. L. 117–129,’’ June 6, 

2022. Available online at: https://www.fns.

usda.gov/wic/implementation-access-baby-formulaact-2022. 

17Ready-to-feed formulas may be authorized only 

under certain circumstances, as specified at 7 CFR 

246.10(e)(1)(iv). 

18U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘Special Supplemental Nutrition 

Program for Women, Infants and Children (WIC): 

Requirements for and Evaluation of WIC Program 

Bid Solicitations for Infant Formula Rebate 

Contracts,’’ 65 FR 51213–51229. (August 23, 2000). 

Available online at: https://

www.federalregister.gov/documents/2000/08/23/00- 

21423/special-supplemental-nutrition-program-forwomen-infants-and-children-wic-requirements-forand#:∼:text=A%20key%20component%20to%20

the%20success%20of%20infant,than%20savings

%20generated%20by%20a%20competitive

%20bidding%20system. 

19U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘WIC Policy Memorandum #99– 

3: Evaluation Criteria for Infant Formula Rebate 

Contracts,’’ October 14, 1998. Available online at: 

https://www.fns.usda.gov/wic/evaluation-criteriainfant-formula-rebate-contracts. 

areas of all WIC State agencies, 

including States, ITOs, and Territories. 

These waivers allowed WIC State 

agencies to benefit from three specific 

remedies to: (1) exceed the maximum 

monthly allowance for infant formula to 

allow for the purchase of larger unit 

sizes; (2) issue non-contract brand 

formula without medical documentation 

(except in Food Package III); and (3) 

receive rebates for non-contract brand 

infant formula, when their contracted 

manufacturer’s product was the subject 

of the recall. As a result, State agencies 

were able to allow for the purchase of 

available formula when the contract 

brand or size was unavailable during 

shortages. Because these three specific 

remedies assisted State agencies with 

meeting participants’ needs during the 

sustained nationwide infant formula 

shortage, such remedies were included 

as suggestions in WIC Policy 

Memorandum #2022–6: Implementation 

of the Access to Baby Formula Act of 

2022–PL 117–129 and are now being 

codified in this rulemaking.16 Exceeding 

the maximum monthly allowance for 

infant formula to allow for the purchase 

of larger unit sizes and issuing noncontract brand formula without medical 

documentation (except in Food Package 

III) will continue to require an approved 

waiver before a State agency can 

operationalize these remedies, and must 

be operationalized within the active 

waivers’ timeframe in order to remain in 

compliance with Program requirements. 

During the sustained nationwide 

infant formula shortage, State agencies 

worked with their infant formula 

contracted manufacturer to collect 

supply data in order to respond to 

participant needs. This data proved 

valuable to State agencies’ ability to 

respond to the shortages. Thus, the 

provision of an action plan, which 

includes supply data, to meet infant 

formula demand and limit disruption to 

Program participants in the affected 

jurisdiction(s) when any contract brand 

infant formula of the contracted 

manufacturer is the subject of a recall 

has been included as a minimum 

remedy in this rule. The State agency 

and contracted manufacturer must 

establish a timeframe by which the 

manufacturer must provide the State 

agency with an action plan following 

the recall of any contract brand infant 

formula of the contracted manufacturer. 

The Department recommends that these 

action plans be provided to State 

agencies within 48 hours following the 

recall of any contract brand infant 

formula of the contracted manufacturer. 

In establishing the remedies, the 

Department considered requiring 

manufacturers to maintain a stockpile of 

infant formula for use in the event of a 

recall. The Department considered 

potential logistics involved, such as: 

types and quantity of formula to 

stockpile, potential locations, the level 

of stockpile maintenance necessary to 

rotate stock, and development of a 

distribution plan related to stockpiling. 

Ultimately, the Department determined 

that the cost and administrative burden 

necessary to require manufacturers to 

maintain a stockpile in excess of 

manufacturers’ usual inventory would 

likely be too extensive for practical 

implementation and would counteract 

any potential benefits for the Program. 

Currently, the Program provides 

infant formula in all three physical 

forms available in the retail 

marketplace, which are powder, liquid 

concentrate, and ready-to-feed.17 While 

7 CFR 246.10(e)(1)(iv) offers State 

agencies the flexibility to issue powder 

or concentrated liquid, 7 CFR 

246.16a(c)(4) requires infant formula 

manufacturers to bid on all three 

physical forms. Currently powder is the 

predominant form in the marketplace 

and some manufacturers do not produce 

liquid concentrate. Requiring liquid 

concentrate in WIC could impact some 

manufacturers’ ability to competitively 

bid and meet contractual requirements. 

Therefore, the Department is seeking 

public comment on the operational and 

financial impacts to the Program of 

modifying the requirement for infant 

formula manufacturers to bid on liquid 

concentrate. Through this rulemaking, 

the Department is not making any 

changes to the current bidding 

requirements at 7 CFR 246.16a(c)(4) or 

the physical forms of infant formula that 

may be issued in accordance with 7 CFR 

246.10(e)(1)(iv). 

2. Clarify Terminology in Infant 

Formula Cost Containment Contracts 

(§ 246.16a(c)(5)) 

This rule clarifies terminology at 7 

CFR 246.16a(c)(5). Specifically, the 

current terms ‘‘responsive and 

responsible’’ used in the regulations to 

describe bidders are consolidated under 

this rulemaking to ‘‘responsive.’’ 

Responsive is further defined for 

clarification, consistent with the intent 

stated in a previous rulemaking 

preamble, Requirements for and 

Evaluation of WIC Program Bid 

Solicitations for Infant Formula Rebate 

Contracts (65 FR 51213–51229), and 

WIC Policy Memorandum #99–3: 

Evaluation Criteria for Infant Formula 

Rebate Contracts.18 19

The inclusion of the terms responsive 

and responsible were initially intended 

to help ensure WIC State agencies select 

formula manufacturers that fully 

respond to the invitation to bid and 

meet eligibility requirements in statute 

and regulation. However, since these 

terms were not defined, they resulted in 

ambiguity in their application. This rule 

removes the responsibility requirement 

and defines the responsiveness 

requirement. Under the modified 

provision, a bidder must submit a bid 

that conforms to the solicitation and 

meets requirements at § 246.16a to be 

considered responsive. The rule adds 

language to clarify this meaning, which 

will provide consistent application of 

the term and ensure that all responsive 

bids will receive consideration. 

C. Add Requirement for State Agency 

Plans of Alternate Operating Procedures 

(§ 246.4(a)) 

This rule adds a new provision 

requiring WIC State agencies to include 

a plan of alternate operating procedures, 

commonly referred to as a disaster plan, 

as part of their State Plan. This 

provision will ensure WIC State 

agencies have plans in place to support 

continuity of operations in the event of 

a disruption of WIC services, including 

but not limited to emergency periods, 

supplemental food recalls, and other 

supply chain disruptions. 

State Plans are submitted annually by 

WIC State agencies as a prerequisite to 

receiving funds. State Plans must be 

updated as needed to reflect substantive 

changes to the State agencies’ Program 

design and operation. Therefore, as a 

part of the State Plan, alternate 

operating procedures must also be 

updated as needed to reflect any 


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86552 Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 

20U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘Guide to Coordinating WIC 

Service During Disasters,’’ January 18, 2022. 

Available online at: https://www.fns.usda.gov/wic/ 

guide-coordinating-wic-service-during-disasters. 

21U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘FNS Handbook 901,’’ January 8, 

2020. Available online at: https://

www.fns.usda.gov/sso/fns-handbook-901-v2- 

advance-planning-documents. 

substantive changes resulting from 

lessons learned as WIC State agencies 

respond to emergency periods and 

supply chain disruptions. Such updates 

will allow WIC State agencies to prepare 

and respond to these events more 

effectively in the future. Additionally, 

FNS encourages WIC State agencies to 

review their State Plans and ensure they 

continue to meet the needs of Program 

stakeholders. State Plans are a vehicle 

through which WIC State agencies can 

outline short- and long-term goals 

necessary to improve Program design 

and operation. For example, State 

agencies may include descriptions of 

goals and action plans to facilitate 

continued improvement in the delivery 

of Program benefits and service during 

Program disruptions as a part of their 

alternate operating procedures. 

Both the COVID–19 public health 

emergency and the 2022 infant formula 

recall and sustained infant formula 

shortage required nearly all WIC State 

agencies to quickly develop and 

implement alternative plans for running 

their programs. While some WIC State 

agencies, such as those with experience 

in dealing with natural disasters, may 

have established alternative operations 

plans, these plans are typically part of 

a broader health department or other 

State agency disaster plan and do not 

address WIC-specific Program 

operations during disruptions nor do 

they typically address other operational 

disruptions beyond natural disasters. 

This resulted in ex post facto 

development of policies and procedures 

and ultimately varying levels of Program 

disruption during the COVID–19 public 

health emergency and the 2022 infant 

formula recall and sustained infant 

formula shortage. These two events 

highlight the need for all WIC State 

agencies to be prepared to continue 

operations when faced with a number of 

potential disruptions. The FNS-required 

alternate operating procedures set 

baseline minimum elements that must 

be included by all WIC State agencies, 

and in turn provide greater transparency 

to FNS on actions each State agency will 

take in the event of a disruption. The 

Department believes that proactive State 

agency development of robust alternate 

operating procedures will minimize the 

negative impact of such disruptions to 

WIC operations and services, position 

State agencies to be better prepared to 

adjust to unexpected situations, and 

ensure the availability of authorized 

supplemental foods, including infant 

formula. 

The Department recognizes that a 

variety of situations, including a 

supplemental food recall, may prompt 

the Secretary to declare a supply chain 

disruption. However, WIC State 

agencies must be prepared to respond to 

supplemental food recalls whether or 

not an official supply chain disruption 

declaration has been made. As such, 

WIC State agencies’ alternate operating 

procedures must specifically and 

directly address supplemental food 

recalls, with an emphasis on infant 

formula recalls, including specialty 

products, as part of the section 

addressing supply chain disruptions as 

a whole. The Department is committed 

to supporting WIC State agencies in 

prioritizing resources and developing a 

separate plan for the distribution of 

specialty formula. 

The Department understands the 

same event may impact WIC State 

agencies differently dependent upon 

their geographic location, participant 

populations, and other factors. As such, 

the Department encourages each WIC 

State agency to consider potential 

events unique to their location and 

identify how the State agency will meet 

the needs of their participant 

populations when developing alternate 

operating procedures. To assist with 

anticipation of potential events, the 

Department expects WIC State agencies 

to establish relationships with relief 

agencies responsible for disaster and 

public health emergency planning 

applicable to the State agency’s 

jurisdiction and participants and 

leverage these relationships as needed. 

Ultimately, the intent of such 

relationships is for the WIC State agency 

to make data-informed decisions in 

order to better meet the needs of their 

jurisdiction’s populations. Nevertheless, 

WIC State agencies must also consider 

the unique and sudden nature of events 

that disrupt regular WIC operations 

when developing alternate operating 

procedures. 

Alternate operating procedures must 

describe the process by which the WIC 

State agency will minimize the negative 

impact to WIC operations and services 

and ensure the availability of authorized 

supplemental foods, especially infant 

formula, to the extent feasible. At a 

minimum, alternate operating 

procedures must include: 

(i) A plan to address operation of 

specific Program areas including: 

a. Access to Program records; 

b. Alternate certification and benefit 

issuance; 

c. Verification of Certification (VOC) 

issuance; 

d. Food package adjustments; 

e. Vendor requirements; 

f. Benefit redemption; and 

g. Food delivery systems. 

(ii) A plan to ensure continuity of 

WIC services and address the needs of 

participants with documented 

qualifying conditions receiving Food 

Package III, rural areas, tribal 

populations, and other priority 

populations in the affected area, as 

applicable; 

(iii) A designated emergency contact 

within the State agency for emergency 

periods, supply chain disruptions, and 

supplemental food recalls; 

(iv) A designated emergency contact 

within the State agency to address the 

needs of participants with documented 

qualifying conditions receiving Food 

Package III; 

(v) A plan to establish a relationship 

with relief agencies responsible for 

disaster and public health emergency 

planning applicable to the State 

agency’s jurisdiction and participants to 

support data-informed approaches when 

responding to emergency periods, 

supplemental food recalls, and other 

supply chain disruptions; 

(vi) A plan to limit the disruption of 

infant formula benefits in the event of 

an emergency period, supplemental 

food recall, and other supply chain 

disruption; 

(vii) A communications plan to keep 

FNS, State and local agency staff, 

authorized WIC vendors, WIC 

participants, and the public informed 

during an emergency period, 

supplemental food recall, or other 

supply chain disruption. 

(viii) A plan to report to FNS on 

alternate operating procedures 

implemented during an emergency 

period, supplemental food recall, and 

other supply chain disruptions, which 

includes Program data and information 

on the impact of benefit use and 

delivery. 

(ix) A plan to adjust State agency 

specific minimum requirements for the 

variety and quantity of supplemental 

foods that a vendor applicant must stock 

to be authorized. 

Minimum requirements outlined in 

this provision reflect current guidance 

found in the Guide to Coordinating WIC 

Service During Disasters.20 In 

developing and implementing the 

alternate procedures, State agencies 

must take into account existing 

requirements for technology projects in 

accordance with FNS Handbook 901.21

For example, if a State agency decides 


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Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 86553 

22U.S. Department of Agriculture, Food and 

Nutrition Service, ‘‘Guide to Coordinating WIC 

Service During Disasters,’’ January 18, 2022. 

Available online at: https://www.fns.usda.gov/wic/ 

guide-coordinating-wic-service-during-disasters. 

to take steps to integrate changes to their 

management information system (MIS) 

to facilitate better service to participants 

during Program disruptions, State 

agencies should consult FNS Handbook 

901 to secure approval and the 

requested funding, if applicable. 

Subsequent to this rulemaking, FNS will 

issue updated guidance to WIC State 

agencies outlining required components 

of the plan and continue to ensure the 

existing guidance found in the Guide to 

Coordinating WIC Service During 

Disasters is up to date and available for 

reference.22 This Guide will also 

provide additional detail regarding 

provisions for WIC State agency 

consideration in development of their 

disaster plans. For example, additional 

alternate operating procedures may 

include: 

• designating alternate means and 

locations for certification and benefit 

issuance for circumstances in which the 

conventional means and locations are 

not possible or optimal; 

• establishing a plan to support 

individuals seeking WIC services 

receiving a full nutrition assessment and 

appropriate referrals; 

• establishing a plan with health care 

centers or other providers of exempt 

infant formula and WIC-eligible 

nutritionals for the distribution of these 

products to participants with 

documented qualifying conditions 

receiving Food Package III 

• developing a WIC formula (infant 

formula, exempt infant formula, or WICeligible nutritional) distribution plan; 

and, 

• if a WIC State agency already has a 

direct distribution or home delivery 

system in place, updating policy to 

specifically include provisions 

reasonable to institute during recalls 

and/or supplemental food shortages. 

Ultimately, this provision is intended 

to minimize adverse impacts to WIC 

operations and the continuation of WIC 

benefits during an emergency period, 

supplemental food recall, and other 

supply chain disruptions impacting 

WIC’s normal operations. Further, 

participants living in rural areas, on 

Tribal lands, following cultural or 

religious food practices, and/or having 

qualifying conditions and receiving 

Food Package III are potentially most 

impacted during an emergency period, 

supplemental food recall, and other 

supply chain disruptions. The 

Department expects this rule to ensure 

more consistent and safe access to the 

foods these most vulnerable participants 

need by anticipating and preparing how 

to meet those needs before any potential 

Program disruptions. This rule will 

allow for more flexibilities in Program 

operations and will require WIC State 

agencies to develop plans to address the 

needs of unique and vulnerable 

populations overall. 

Finally, the Department recognizes 

WIC is not designed to be a disaster 

assistance program and is not 

considered a first response option for 

disaster survivors. As such, the 

Department continues to encourage WIC 

State agencies to work with State and 

local emergency services offices, as well 

as the Federal Emergency Management 

Agency (FEMA), to the maximum extent 

practicable, to provide participants with 

a coordinated disaster response during 

an emergency period. 

IV. Implementation 

Because the majority of the revisions 

described in this rulemaking are 

introducing opportunities for increased 

flexibility for WIC State agencies, this 

final rule will take effect 60 days after 

publication, except for § 246.4(a), which 

is the provision requiring WIC State 

agencies to include, as a part of the State 

Plan, a plan of alternate operating 

procedures, commonly referred to as a 

disaster plan, in accordance with FNS 

guidance. 

For § 246.4(a), these changes are 

required to be implemented with State 

agency FY 2025 State Plan submissions, 

due to FNS no later than August 15, 

2024. This timeline recognizes WIC 

State agencies will need the time to 

develop and refine their alternate 

operating procedures to meet the 

requirements of this provision. 

Per WIC Policy Memorandum #2022– 

6: Implementation of the Access to Baby 

Formula Act of 2022—PL 117–129, all 

contracts entered into or renewed on or 

after May 21, 2022, the date of 

enactment of ABFA, are expressly 

required by law to include language in 

their WIC infant formula rebate 

contracts that describes remedies in the 

event of an infant formula recall, 

including how an infant formula 

manufacturer would protect against 

disruption to Program participants in 

the State (i.e., ensure that WIC 

participants can purchase formula using 

WIC benefits). Section 246.16a as 

amended codifies these requirements 

and the provisions as described herein 

must be strictly applied to all infant 

formula contracts entered into or 

renewed once the final rule takes effect. 

FNS considers a new contract to be 

entered into upon award after a 

competitively bid process. 

The Department seeks comments from 

WIC State agencies on the type and 

scope of administrative burden that may 

be associated with implementing the 

provisions in this rule in this manner. 

Procedural Matters 

Executive Order 12866, 13563 and 

14094 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), Executive Order 14094 entitled 

‘‘Modernizing Regulatory Review’’ 

(April 6, 2023), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, section 202 of 

the Unfunded Mandates Reform Act of 

1995 (March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999), and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Orders 12866, 13563 and 

13563 direct agencies to assess all costs 

and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). The Executive Order 14094 

entitled ‘‘Modernizing Regulatory 

Review’’ (hereinafter, the Modernizing 

E.O.) amends section 3(f)(1) of Executive 

Order 12866 (Regulatory Planning and 

Review). The amended section 3(f) of 

Executive Order 12866 defines a 

‘‘significant regulatory action’’ as an 

action that is likely to result in a rule: 

(1) having an annual effect on the 

economy of $200 million or more in any 

1 year (adjusted every 3 years by the 

Administrator of OIRA for changes in 

gross domestic product), or adversely 

affect in a material way the economy, a 

sector of the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or State, local, 

territorial, or tribal governments or 

communities; (2) creating a serious 

inconsistency or otherwise interfering 

with an action taken or planned by 

another agency; (3) materially altering 

the budgetary impacts of entitlement 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof; or (4) raise legal or policy issues 

for which centralized review would 

meaningfully further the President’s 

priorities or the principles set forth in 

the Executive Order, as specifically 

authorized in a timely manner by the 

Administrator of OIRA in each case. 


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86554 Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 

23Caulfield, L., Bennett, W., Gross, S., Hurley, K., 

Ogunwole, S., Venkataramani, M., Lerman, J., 

Zhang, A., Sharma, R., Bass, E. (2022). Maternal and 

Child Outcomes Associated with the Special 

Supplemental Nutrition Program for Women, 

Infants, and Children (WIC). Comparative 

Effectiveness Review No. 253. Prepared by the 

Johns Hopkins University Evidence-based Practice 

Center under Contract No. 75Q80120D00003.) 

AHRQ Publication No. 22–EHC019. Rockville, MD: 

Agency for Healthcare Research and Quality. DOI: 

https://doi.org/10.23970/AHRQEPCCER253. 

24U.S. Department of Agriculture Food and 

Nutrition Service. WIC Data Tables, 2021. Available 

online at: https://www.fns.usda.gov/pd/wicprogram. 

A regulatory impact analysis (RIA) 

must be prepared for major rules with 

significant regulatory action/s and/or 

with significant effects as per section 

3(f)(1) ($200 million or more in any 1 

year). Based on our estimates, OMB’s 

Office of Information and Regulatory 

Affairs has determined that this 

rulemaking is ‘‘significant’’ and not 

‘‘major’’ under Subtitle E of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (also known as the 

Congressional Review Act).’’ Therefore, 

OMB has reviewed this final regulation, 

and the Department has provided the 

following assessment of their impact. 

Regulatory Impact Analysis 

As required for all rules designated as 

Significant by the Office of Management 

and Budget, an economic summary was 

developed for this final rule. The 

following summarizes the conclusions 

of the regulatory impact analysis: 

Need for Action: As described in the 

preamble, this rulemaking serves to 

amend the Special Supplemental 

Nutrition Program for Women, Infants, 

and Children (WIC) Program regulations 

by incorporating provisions of the 

Access to Baby Formula Act of 2022 

(ABFA) and making related 

amendments. ABFA establishes waiver 

authority for the Secretary of 

Agriculture to address certain 

emergencies, disasters, and supply 

chain disruptions impacting the WIC 

Program, and adds requirements to State 

agency infant formula cost containment 

contracts to protect against disruptions 

to the Program in the event of a recall. 

The amendments made via this rule are 

expected to improve State agencies’ 

ability to ensure continuity of Program 

operations during emergencies, 

disasters, and supply chain disruptions, 

while ensuring access to Program 

benefits among low-income infants, 

children, and pregnant, postpartum, and 

breastfeeding individuals. 

Affected Parties: WIC participants and 

those involved in the provision of infant 

formula to WIC participants, including 

the USDA Food and Nutrition Service 

(FNS), State and local agencies, 

including Indian Tribal Organizations 

(ITOs), clinics, infant formula 

manufacturers, and retail vendors. 

I. Statement of Need 

On May 21, 2022, the Access to Baby 

Formula Act of 2022 (Pub. L. 117–129) 

was signed into law. ABFA amends 

Section 17 of the Child Nutrition Act of 

1966 (CNA, 42 U.S.C. 1786) to (1) 

establish waiver authority to the 

Secretary of Agriculture to address 

certain emergencies, disasters, and 

supply chain disruptions impacting the 

WIC Program; and (2) require State 

agency infant formula cost containment 

contracts to include specific remedies to 

protect against disruptions to the 

Program in the event of a recall. This 

rule amends 7 CFR part 246 to codify 

the provisions of ABFA, which 

strengthens WIC’s ability to address 

emergencies, disasters, and supply 

chain disruptions, particularly those 

impacting infant formula. 

II. Background 

Established in 1974, the mission of 

the Special Supplemental Nutrition 

Program for Women, Infants, and 

Children (WIC) is to safeguard the 

health of low-income pregnant, 

postpartum, and breastfeeding 

individuals, infants, and children ages 1 

through 4 years who are at nutritional 

risk by providing nutritious foods to 

supplement diets, nutrition education 

(to include breastfeeding promotion and 

support), and referrals to health and 

other social services. Participation in 

WIC is associated with improved 

pregnancy outcomes and lower infant 

mortality. WIC participation is also 

associated with improved diet quality.23

In Federal fiscal year (FY) 2022, WIC 

served an average of 6.24 million 

infants, children, and pregnant, 

breastfeeding, and postpartum 

individuals per month.24

On March 13, 2020, the President 

declared the ongoing COVID–19 a 

public health emergency of sufficient 

severity and magnitude to warrant 

declaration of a nationwide emergency. 

The President later approved major 

disaster declarations for State agencies, 

including Indian Tribal Organizations 

and U.S. Territories pursuant to section 

501(b) of the Stafford Act. 

On March 18, 2020, the Families First 

Coronavirus Response Act (FFCRA, Pub. 

L. 116–127) was signed into law to 

assist with the COVID–19 public health 

emergency, which provided additional 

funding for WIC and offered additional 

flexibilities by providing USDA with 

authority to grant certain programmatic 

waivers to State agencies to enable WIC 

to continue serving WIC participants in 

the midst of a public health crisis (e.g., 

the physical presence requirement was 

waived to encourage social distancing 

and reduce in-person visits to WIC 

clinics). 

On February 17, 2022, a major infant 

formula manufacturer voluntarily 

recalled certain powder infant formula, 

including exempt infant formula. This 

recall exacerbated existing supply chain 

issues resulting from the ongoing 

COVID–19 public health emergency. In 

response to this recall, USDA used its 

limited waiver authority granted under 

Section 301 of the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act, ‘‘Stafford Act’’ (42 

U.S.C. 5121) to help WIC participants 

obtain infant formula. This was possible 

because of existing COVID–19 major 

disaster declarations in all WIC State 

agencies, including States, Indian Tribal 

Organizations, and U.S. Territories. 

While the existing COVID–19 major 

disaster declaration and resulting 

Stafford Act authority provided a 

vehicle through which USDA could 

grant WIC State agencies waivers, under 

normal circumstances such waiver 

authority would not typically be 

available for the Department to respond 

to an infant formula recall, nor could 

the Department issue nationwide 

waivers. As a result, Congress 

recognized the need to provide longterm waiver flexibilities, and the 

President signed ABFA into law on May 

21, 2022, in direct response to the infant 

formula recall. ABFA amended Section 

17 of the Child Nutrition Act of 1966 (42 

U.S.C. 1786) to (1) establish waiver 

authority to the Secretary of Agriculture 

to address certain emergencies, 

disasters, and supply chain disruptions 

impacting the WIC Program; and (2) 

require WIC State agency infant formula 

cost containment contracts to include 

specific remedies to protect against 

disruptions to the Program in the event 

of a recall. 

This rule amends 7 CFR part 246 to 

codify the provisions of ABFA. 

III. List of Rule Provisions and Impacts 

Most of the provisions in this rule are 

required by ABFA; the provisions added 

by the Secretary that go beyond ABFA’s 

requirements are noted below and 

include consolidating language in the 

regulations to describe bidders to 

‘‘responsive’’ and requiring State 

agencies to create plans of alternate 

operating procedures. A list of the rule’s 

provisions and a discussion of their 

likely impacts to the WIC Program, on 

Program cost, and on affected parties 

follows. 


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25Almost all State agencies (88 of 89 State 

agencies) used a physical presence waiver 

sometime during the COVID–19 pandemic. For 

more information on physical presence waivers by 

State agency, see https://www.fns.usda.gov/ 

disaster/pandemic/covid-19/wic-physical-presencewaiver. 

26A large majority of State agencies (70 of 89) 

issued food package substitution waivers for one or 

more food types. For more information on food 

package substation waivers by State agency, see 

https://www.fns.usda.gov/wic/food-packagesubstitution-waiver. 

27Unpublished data collected by USDA as a part 

of State agency reporting on FFCRA waiver use. 

These data will be released in an upcoming USDA 

report. 

28 Ibid. 

29WIC program data for the periods before and 

during the COVID–19 pandemic (available online at 

https://www.fns.usda.gov/pd/wic-program) do not 

show any substantial increase or decrease in WIC 

spending, in spite of the hundreds of waivers in 

place during the COVID–19 pandemic. 

A. Add Waiver Authority Granted by 

the Access to Baby Formula Act 

1. Add New Definitions 

i. Program Impact: This rule adds 

definitions of Emergency period, 

Qualified administrative requirement, 

Recall, and Supply chain disruption in 

order to incorporate ABFA statutory 

language. 

ii. Cost Impact: USDA estimates no 

change in cost associated with this 

provision. This change merely adds 

definitions required for operational 

clarity under ABFA. 

iii. Impact on Affected Parties: USDA 

estimates no impact on affected parties. 

Impacts on affected parties that arise 

due to other provisions of this rule are 

discussed below. 

2. Specify Criteria for Establishing 

Waivers or Modification and 

Timeframes for Use 

i. Program Impact: This rule creates a 

new provision at § 246.29 that specifies 

(1) criteria under which a waiver or 

modification may be established, (2) 

information State agencies must provide 

to FNS when requesting a waiver, and 

(3) the timeframes during which waivers 

will remain available for use by State 

agencies. One recent example of a 

category of waivers is physical presence 

waivers.25 The Families First 

Coronavirus Response Act gave USDA 

authority to grant waivers to State 

agencies of the requirement that all 

individuals seeking to enroll or re-enroll 

in WIC do so in person (i.e., physical 

presence). This waiver also allowed 

State agencies to defer certain 

anthropometric (i.e., height/length and 

weight) and bloodwork requirements 

used to determine nutritional risk. The 

physical presence waiver allowed 

USDA to encourage social distancing 

and decrease the spread of COVID–19 

while ensuring continuity of operations 

for State and local WIC agencies and for 

WIC participants. 

A second recent example of a category 

of waivers are the food package 

substitution waivers.26 These waivers 

allowed State agencies to permit 

approved substitutes for the types and 

amounts of certain WIC-prescribed 

foods if their availability is limited. For 

example, as appropriate based on local 

food marketplace circumstances, State 

agencies were approved, upon request, 

to allow participants to substitute milk 

of any available fat content if prescribed 

varieties are not available; substitute 

authorized whole grains in package 

sizes up to 24 oz. when 16 oz. packages 

are not available; and/or substitute 18- 

count cartons of eggs when 12-count 

cartons are unavailable. These waivers 

enabled WIC participants to continue to 

receive appropriate supplemental foods 

during shortages of the specific products 

and/or package sizes that were 

previously authorized by the State 

agencies. 

ii. Cost Impact: USDA was unable to 

reliably estimate the change in cost 

associated with this provision, beyond 

the very slight change in burden hours 

(38 hours across all State agencies 

annually) associated with this 

provision. Although USDA estimates a 

negligible increase in burden hours due 

to this provision, USDA also notes that 

formalizing the criteria for establishing 

waivers and timeframes for waiver use 

makes the waiver process more 

predictable for both State agencies and 

the Federal government and greatly 

decreases the likelihood of repeated 

waiver revisions and submissions in 

order to meet waiver requirements. 

USDA is unable to reliably quantify the 

costs of future waivers since the types 

and scope/scale of future waivers will 

be in response to unknown events. 

USDA notes that some waivers have the 

possibility to increase or decrease the 

cost of the Program, though USDA 

generally expects these possible cost 

impacts to be small. For example, it is 

possible that the physical presence 

waiver either increased or decreased 

administrative costs for some local WIC 

clinics, depending on whether the local 

clinics increased or decreased staffing or 

office space in response to moving to 

phone or online certification/ 

recertification of participants. Ninetynine percent of State agencies reported 

that the physical presence waivers were 

‘‘very’’ or ‘‘extremely important’’ to 

ensuring quality services during the 

COVID–19 pandemic, and some State 

agencies reported that the physical 

presence waivers allowed them to serve 

more participants with fewer staff or in 

less time, which points to potential cost 

savings generated by the physical 

presence waivers.27 Similarly, food 

package substitution waivers may 

increase or decrease food costs slightly, 

depending on whether the food package 

substitutions are for items slightly more 

or less expensive than those typically 

included in the food package. 

Approximately 90 percent of State 

agencies reported that the food 

substitution waivers were ‘‘very 

important’’ or ‘‘extremely important’’ to 

ensuring quality services during the 

COVID–19 pandemic, pointing to the 

waivers’ contribution to ensuring 

continued operations during the 

pandemic.28 Neither the physical 

presence waiver nor the food package 

substitution waivers issued during the 

COVID–19 pandemic were found to 

result in significant increases or 

decreases in WIC spending at the 

Federal level.29 In FY2019, FY2020, and 

FY2021, Federal spending on WIC was 

$5.3, $5.0, and $5.0 billion, respectively, 

while participation during the same 

Fiscal Years was 6.4, 6.2, and 6.2 

million individuals. Therefore, the 

effect of waivers in the aggregate during 

the COVID–19 emergency does not 

appear to have had a significant effect 

on Federal WIC costs, though it is 

possible that individual waivers may 

have increased or decreased Federal 

WIC costs. 

The use of waivers in the past has 

generally focused on ensuring 

continued operation of the WIC Program 

as normally as possible under temporary 

and extraordinary circumstances. 

Waiver authority as authorized by 

ABFA must continue to be used 

primarily for this purpose; therefore, 

USDA does not predict that the future 

use of waivers will lead to either 

substantial costs or savings. 

iii. Impact on Affected Parties: USDA 

estimates an increase in burden on State 

agencies as a result of this provision, but 

this provision will also clarify and 

standardize the steps that a State agency 

must undertake in order to submit a 

waiver request, which could save some 

State agencies effort in the long run by 

preventing State agencies from having to 

resubmit waiver requests multiple times 

because their initial requests do not 

meet the waiver requirements or do not 

provide enough information for FNS to 

understand why the waiver is necessary 

in order to continue Program operations. 

USDA also notes that waiver authority 

has generally been granted to FNS 

programs when it was needed in the 

past, and this provision does not make 


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30Analysis of FNS administrative data, available 

at https://www.fns.usda.gov/pd/wic-program. 

31See http://flca.info/HTMLobj-154/Recalls.pdf. 

Accessed December 7, 2022. 

the process for requesting a waiver more 

burdensome than it already was when 

FNS implemented waivers during the 

COVID–19 public health emergency. 

More generally, waiver authority allows 

USDA and State and local WIC agencies 

to continue to operate the WIC Program 

as intended during extraordinary times, 

without compromising the quality of 

WIC services or supplemental nutrition 

and without increasing the burden on 

WIC participants. Clear requirements 

and a simplified waiver process will 

allow State agencies and USDA to put 

waivers in place more quickly, enabling 

State agencies and USDA to rapidly 

respond to emergency situations and 

meet waiver applicant and participant 

needs. 

B. Update Requirements for State 

Agency Infant Formula Cost 

Containment Contracts 

1. Establish Minimum Required 

Remedies for Infant Formula Cost 

Containment Contracts 

i. Program Impact: While ABFA 

generally requires that infant formula 

cost containment contracts include 

remedies to protect against disruption to 

Program participants in the event of an 

infant formula recall, this rulemaking 

codifies into regulations specific 

minimum remedies that assisted State 

agencies with meeting participants’ 

needs during a major infant formula 

recall. The minimum remedies must 

include (1) that infant formula issuance 

may exceed the maximum monthly 

allowance to allow for the purchase of 

all unit sizes; (2) non-contract brand 

formula can be issued without medical 

documentation (except in Food Package 

III); and (3) when the contracted brand 

infant formula is the subject of the 

recall, require the contracted infant 

formula manufacturer to provide the 

State agency with an action plan, which 

includes supply data, to meet infant 

formula demand and limit disruption to 

Program participants in the affected 

jurisdiction(s) within 10 calendar days 

of the recall, and pay rebates on 

competitive, non-contract brand infant 

formula that meets the definition of 

infant formula at 7 CFR 246.2. WIC State 

agencies may work with their legal 

counsel and procurement offices to 

include additional remedies beyond 

these regulatory minimum remedies in 

their infant formula contracts. WIC State 

agencies may also negotiate flexibilities 

that are within regulatory requirements 

and do not require Program waivers 

with their contracted infant formula 

manufacturers. 

ii. Cost Impact: USDA was unable to 

reliably estimate the change in costs 

associated with this provision, beyond 

the small change in burden hours (148 

hours across all State agencies annually) 

associated with this provision. Although 

USDA acknowledges that there will be 

cost impacts associated with this 

provision in the event of future recalls, 

at this time, USDA is unable to reliably 

quantify the costs of future remedies, 

since the types and scope/scale of future 

remedies will be in response to 

unknown events, and therefore, USDA 

does not include a formal estimate of 

the 5-year cost of this provision. Instead, 

the following section provides a historic 

look at the frequency, scale, and cost of 

previous infant formula recalls for 

illustrative purposes as well as an 

estimate of the cost impact that could 

result from even modest changes to 

infant formula contract rebate rates. 

The first two parts of the provision 

grant administrative flexibilities to 

ensure continued formula supply to 

WIC participants (1) by enabling State 

agencies to issue all unit sizes and, in 

some cases, exceed the maximum 

monthly allowance for formula during 

issuance if some package sizes are not 

available in the local marketplace (2) by 

enabling State agencies to issue noncontract brand formula without medical 

documentation (except in Food Package 

III) in the event that the contract brand 

formula is unavailable. 

The third part of the provision—that 

the contracted infant formula 

manufacturer will pay rebates on 

competitive non-contract brand infant 

formula when the contracted infant 

formula manufacturer’s product is the 

subject of the recall—has the potential 

to impose costs on infant formula 

manufacturers. As described above, 

during the most recent major infant 

formula recall, the infant formula 

manufacturer whose product was the 

subject of the voluntary recall 

temporarily continued paying rebates on 

competitive non-contract brand infant 

formula in the WIC State agencies where 

they held the contract. Adding this 

remedy to future infant formula cost 

containment contracts requires all infant 

formula manufacturers to pay these 

rebates in the future when their product 

is the subject of a recall, which in turn 

could pose an added cost to the 

manufacturer subject to the recall while 

their product is off the market. 

In the event that a supply chain 

disruption necessitates issuing a waiver 

to a State agency allowing the issuance 

of non-contract infant formula without 

medical documentation, but where the 

contracted infant formula manufacturer 

in that State agency is not the subject of 

a recall and thus not obligated to pay 

rebates on non-contract products as 

described above, then USDA expects to 

see a decrease in rebate income relative 

to the amount of non-contract brand 

formula issued in that State agency. Any 

decrease in rebate income relative to the 

amount of non-contract brand formula 

issued would increase WIC food 

expenditures on infant formula for 

USDA, as was the case in State agencies 

without contracts with a specific major 

infant formula manufacturer during the 

2022 major infant formula recall. While 

the Department is not able to estimate 

the scale of future recalls, a look back 

at typical infant formula rebate 

amounts, prior to the 2022 voluntary 

recall by a major infant formula 

manufacturer of certain powder infant 

formula, including exempt infant 

formula, provides a helpful estimate of 

possible costs. USDA received 

approximately $1.6 billion in WIC 

infant formula rebates in FY 2021, while 

the monthly average number of fully 

formula-fed infant participants was 

approximately 962,000, and the 

monthly average number of partially 

breastfed infant participants was 

approximately 329,000, resulting in an 

average monthly rebate of $103.38 per 

infant receiving a WIC food package 

with infant formula. As an example of 

scale, it would therefore cost USDA 

around $10.3 million to cover the lost 

rebate amounts for 100,000 average 

infants receiving formula per month, 

based on FY 2021 costs.30

Our analysis suggests that most infant 

formula recall events in the past 20 

years have been recalls of small 

amounts of products—usually single 

batches or lot numbers, and almost all 

covering fewer than around 100,000 

cans of infant formula per recall—and 

would not require the kind of large-scale 

intervention that the major infant 

formula recall in 2022 required. One 

available list of infant formula recalls 

from 1982–2005 showed no large 

nationwide recalls (except for one in 

2001 that was a result of mislabeling, 

not product contamination).31 Similarly, 

a search of FDA’s Enforcement Database 


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Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 86557 

32Search available at https://www.fda.gov/safety/ 

recalls-market-withdrawals-safety-alerts/ 

enforcement-reports. Accessed December 7, 2022. 

33Costs associated with State agency burden 

hours are calculated using the hourly total 

compensation for all State and Local workers from 

the Bureau of Labor and Statistics (BLS) for FY 2021 

and inflated according to the CPI–W increase in 

OMB’s economic assumptions for the FY2023 

President’s Budget for years FY2024–FY2028 

(https://data.bls.gov/timeseries/CMU301000

0000000D). 

showed only small recalls of infant 

formula (fewer than 100,000 cans per 

recall that likely did not disrupt the 

supply chain) from June 2012 through 

2022, until the large major infant 

formula recall.32

Finally, USDA notes that these 

provisions may impact rebate amounts 

offered on infant formula contracts 

moving forward. If this rule changes the 

incentive for infant formula 

manufacturers to increase or decrease 

rebate bids on infant formula contracts 

through the competitive bidding 

process, it could increase or decrease 

the rebate amounts offered by infant 

formula manufacturers to State 

Agencies. This would consequently 

decrease or increase Federal WIC food 

costs. However, when examining the 

limited number of infant formula 

contracts awarded either (1) since the 

start of the major infant formula recall, 

or (2) since the passage of ABFA, which 

included contracts that require the three 

remedies outlined in this rule, USDA 

was not able to discern a pattern of 

either increased or decreased formula 

rebate bids; some offered rebate 

amounts increased slightly and others 

decreased slightly, similar to how 

formula contracts have changed over 

time in the past. Therefore, USDA is not 

able to estimate that these provisions 

will have an impact on the rebates 

offered in future infant formula 

contracts. However, to provide a sense 

of scale, USDA notes that WIC received 

$1.6 billion in rebates from infant 

formula and food manufacturers in 

FY2021; a nationwide 5 percent 

increase or decrease in average infant 

formula rebate amounts offered to State 

agencies would decrease or increase 

Federal WIC food spending by $80 

million per year. 

iii. Impact on Affected Parties: The 

extent to which other impacts of these 

provisions will be realized largely 

depends on how often and at what scale 

they are needed in responding to future 

recalls. In the event that an infant 

formula manufacturer is never subject to 

a recall, then the impact of these 

remedies on infant formula 

manufacturers will be minimal.In the 

event of a recall, these provisions grant 

substantial benefits to WIC State and 

local agencies, WIC vendors, and WIC 

participants. The minimum remedies 

described above benefit WIC State 

agencies by providing a substantially 

streamlined administrative process to 

approve and issue new infant formula 

benefits in the event of a recall. WIC 

vendors benefit from the certainty that 

WIC participants will continue to be 

issued and be able to purchase infant 

formula. Finally, these remedies are 

intended to protect WIC participants 

from disruptions in access to infant 

formula during product recalls. For 

infant formula manufacturers, if their 

product is subject to a recall these 

provisions will require them to pay 

rebates on non-contract infant formula 

in their contracted State agencies. 

However, these provisions also provide 

certainty as to how all stakeholders in 

the WIC infant formula supply chain— 

the Federal Government, State and local 

WIC agencies, WIC vendors, WIC 

clinics, and infant formula 

manufacturers—will respond and what 

responsibilities they bear in the event of 

a formula recall. 

2. Clarify Terminology in Infant 

Formula Cost Containment Contracts 

i. Program Impact: This rule will 

clarify terminology at 7 CFR 

246.16a(c)(5). Specifically, the current 

terms ‘‘responsive and responsible’’ 

used in the regulations to describe 

bidders are consolidated to 

‘‘responsive.’’ Responsive is further 

defined for clarification; to be 

responsive, a bidder must submit a bid 

that conforms to the solicitation and 

must meet requirements at 246.16a. The 

rule adds language to clarify this 

meaning, which will enhance consistent 

application of the term and ensure that 

all responsive bids will receive 

consideration. This provision is not 

required by ABFA. 

ii. Cost Impact: USDA is not able to 

estimate a change in cost associated 

with this provision. Improved clarity 

may slightly lower administrative costs 

to State agencies or infant formula 

manufacturers. 

iii. Impact on Affected Parties: This 

change improves the clarity of the 

bidding process for infant formula 

contracts between State agencies and 

infant formula manufacturers. 

C. Add Requirement for State Agency 

Plans of Alternate Operating Procedures 

i. Program Impact: This rule will add 

a new provision that State agencies 

must include as a part of the State Plan 

a plan of alternate operating procedures, 

commonly referred to as disaster plans, 

in the event of a disruption of WIC 

services. Requiring States to have these 

plans in place prior to a disaster will 

help mitigate potential impacts as States 

would have uniform baseline measures 

in place to address potential barriers to 

Program operations and allow State 

agencies to respond more quickly 

during these unforeseen events. This 

provision is not required by ABFA. 

ii. Cost Impact: USDA was unable to 

estimate the change in cost associated 

with this provision, beyond the change 

in burden hours (1,869 hours across all 

State agencies annually) associated with 

this provision. Some State agencies may 

already include components of a plan of 

alternate operating procedures in their 

State Plan; for these State agencies, this 

provision poses a minimal additional 

burden to update their procedures in 

accordance with regulations. Although 

there may be a small increase in burden 

as State agencies write alternative 

operating procedures to include in 

future State Plans, USDA anticipates 

that having these plans in place may 

decrease burden on State agencies and 

improve State agencies’ responsiveness 

during a disaster, although USDA is not 

able to quantify these potential benefits. 

iii. Impact on Affected Parties: USDA 

anticipates a small increase in burden 

on some State agencies. However, USDA 

expects that having these plans in place 

will leave State agencies more prepared 

in the event of a disaster and will help 

mitigate the disruptions WIC 

participants might face in the event of 

a disaster. 

IV. Summary of Impacts 

A. Cost Impact 

The costs of the rule that were able to 

be estimated are the result of an increase 

in reporting and recordkeeping burden 

associated with the provisions of the 

rule (an increase of 2,055 reporting and 

recordkeeping hours annually across all 

State agencies), most of which are due 

to the provision requiring alternative 

operating procedures in State Plans. 

USDA estimates these costs to be $0.6 

million to the State agencies over the 

five years from FY 2024 to FY 2028.33


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34Amounts may not sum to the total shown due 

to rounding. 

35See, for example, Oliveira, V. and Fraza ̃o, E. 

(2015), ‘‘Painting a More Complete Picture of WIC: 

How WIC Impacts Nonparticipants,’’ available 

online at https://www.ers.usda.gov/amber-waves/ 

2015/april/painting-a-more-complete-picture-ofwic-how-wic-impacts-nonparticipants/. 

TABLE 1—ESTIMATED STATE AGENCY COSTS DUE TO CHANGE IN ADMINISTRATIVE 34 BURDEN, FY 2024–2028 

Fiscal year 

(millions) 

2024 2025 2026 2027 2028 Total 

Increase in State Agency Reporting and Recordkeeping Burden $ 0.1 $ 0.1 $ 0.1 $ 0.1 $ 0.1 $ 0.6 

B. Benefit Impact 

As discussed in detail above, the 

provisions of this rule strengthen USDA 

and WIC State agencies’ ability to 

address emergencies, disasters and 

supply chain disruptions, particularly 

those impacting infant formula by (1) 

codifying permanent, expanded waiver 

authority of the Secretary to help ensure 

continuity of WIC services during 

certain emergencies, disasters, and 

supply chain disruptions impacting the 

WIC Program; (2) codifying 

requirements for State agencies to 

include language in their WIC infant 

formula cost containment contracts that 

describes remedies in the event of an 

infant formula recall, including how an 

infant formula manufacturer would 

protect against disruption to benefit 

access by WIC participants, and (3) 

requiring that State agencies include as 

a part of their State Plans a ‘‘plan of 

alternate operating procedures’’ in the 

event of an emergency period, supply 

chain disruption, or supplemental food 

recall. 

Although USDA is not able to 

quantify the benefits generated by this 

rule, USDA expects for the provisions of 

this rule to improve the Federal 

Government’s and State agencies’ 

readiness to respond to emergencies, 

disasters, or supply chain disruptions. 

Improved readiness should decrease 

uncertainty to State and local WIC 

agencies, WIC clinics, infant formula 

manufacturers, WIC-authorized vendors, 

and WIC participants and should 

improve the continued provision of WIC 

services and benefits to WIC 

participants in the event of a 

emergencies, disasters, or supply chain 

disruption. 

C. Participation and Distributional 

Impacts 

As noted in the above analysis, the 

Department does not project a 

participation impact attributable to this 

rule; the changes made by this rule are 

largely administrative in nature and 

strive to ensure continued, smooth 

operation of WIC during extraordinary 

events. The changes are unlikely to be 

visible to WIC-eligible individuals and 

WIC participants in a way that affects 

their decision to participate or continue 

to participate in the WIC Program. 

Previous analyses have studied the 

effects that WIC has on individuals who 

do not participate in WIC.35 The 

Department is unable to reliably 

estimate an effect of this rule on nonWIC participants, as the provisions of 

this rule that are non-administrative and 

not costed (i.e., the non-administrative 

consequences of the waiver provisions 

and the infant formula contract 

provisions) do not come into force 

except in response to future, 

unpredictable events. Furthermore, the 

limited datapoints the Department does 

have do not indicate that this rule is 

likely to affect infant formula rebates in 

a meaningful way and, therefore, is 

unlikely to affect the wider infant 

formula market. To the extent that the 

provisions of this rule helps ensure 

continued infant formula supply in the 

event of a supply chain disruption, this 

rule could have positive spillover effects 

on non-WIC participants, as the infant 

formula available for purchase to WIC 

participants will also be available for 

purchase by non-WIC participants. 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601–612) requires agencies to 

analyze the impact of rulemaking on 

small entities and consider alternatives 

that would minimize any significant 

impacts on a substantial number of 

small entities. Pursuant to that review, 

it has been certified this rule would not 

have a significant impact on a 

substantial number of small entities. 

This final rule would not have a 

significant economic impact on a 

substantial number of small entities. 

This final rule would not have an 

adverse impact of small entities in the 

WIC; the impact is not significant as it 

allows for greater options and 

flexibilities to support the continuation 

of WIC services during emergency 

periods and supply chain disruptions. 

State agencies are already required to 

continuously operate a cost containment 

system for infant formula, with some 

exceptions. Notably, ITOs with 1,000 or 

fewer participants are exempt from this 

provision. Further, the Department has 

encouraged WIC State agencies to 

develop disaster plans in the event of 

disruptions to Program operations. Of 

the 89 WIC State agencies, 82 State 

agencies have disaster plans in place. 

Factual Basis 

The provisions of this final rule apply 

to small local agencies operating the 

Special Supplemental Nutrition 

Program for Women, Infants and 

Children, and to State agency staff who 

must monitor local agencies in remote 

locations. These entities meet the 

definitions of ‘‘small governmental 

jurisdiction’’ and ‘‘small entity’’ in the 

Regulatory Flexibility Act. These 

entities will not be negatively impacted 

by the changes and options in this rule. 

Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), the Office of 

Information and Regulatory Affairs 

designated this rule as not a ’major rule’ 

as defined by 5 U.S.C. 804(2). 

Unfunded Mandates Reform Act 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Public 

Law 104–4, establishes requirements for 

Federal agencies to assess the effects of 

their regulatory actions on State, local 

and tribal governments, and the private 

sector. Under section 202 of the UMRA, 

the Department generally must prepare 

a written statement, including a cost 

benefit analysis, for proposed and final 

rules with ‘‘Federal mandates’’ that may 

result in expenditures by State, local or 

tribal governments, in the aggregate, or 

the private sector, of $177 million or 

more in 2023 (when adjusted for 

inflation; GDP deflator source: Table 

1.1.9 at http://www.bea.gov/iTable) in 

any one year. When such a statement is 

needed for a rule, Section 205 of the 

UMRA generally requires the 

Department to identify and consider a 

reasonable number of regulatory 

alternatives and adopt the most cost 

effective or least burdensome alternative 

that achieves the objectives of the rule. 


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Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 86559 

This final rule does not contain 

Federal mandates (under the regulatory 

provisions of Title II of the UMRA) for 

State, local and tribal governments, or 

the private sector of $146146177146146 

million or more in any one year. Thus, 

the rule is not subject to the 

requirements of Sections 202 and 205 of 

the UMRA. 

Executive Order 12372 

The Special Supplemental Nutrition 

Program for Women, Infants, and 

children (WIC) is listed in the Catalog of 

Federal Domestic Assistance under 

Number 10.557 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 2 CFR 

chapter IV.) 

Federalism Summary Impact Statement 

Executive Order 13132 requires 

Federal agencies to consider the impact 

of their regulatory actions on State and 

local governments. Where such actions 

have federalism implications, agencies 

are directed to provide a statement for 

inclusion in the preamble to the 

regulations describing the agency’s 

considerations in terms of the three 

categories called for under Section 

(6)(b)(2)(B) of Executive Order 13132. 

The Department has considered the 

impact of this rule on State and local 

governments and has determined that 

this rule does not have federalism 

implications. Therefore, under Section 

6(b) of the Executive Order, a federalism 

summary is not required. 

Executive Order 12988, Civil Justice 

Reform 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule is intended to 

have preemptive effect with respect to 

any State or local laws, regulations, or 

policies which conflict with its 

provisions or which would otherwise 

impede its full and timely 

implementation. This rule is not 

intended to have retroactive effect 

unless so specified in the Effective Dates 

section of the final rule. Prior to any 

judicial challenge to the provisions of 

the final rule, all applicable 

administrative procedures must be 

exhausted. 

Civil Rights Impact Analysis 

FNS has reviewed the final rule, in 

accordance with the Department 

Regulation 4300–004 ‘‘Civil Rights 

Impact Analysis,’’ to identify and 

address any major civil rights impacts 

the proposed rule might have on 

participants on the basis of race, sex, 

national origin, disability, and age. The 

requirements outlined in the final rule 

aim to remove barriers to WIC food 

access. The changes would impact WIC 

State agencies, including ITOs, WIC 

local agencies and clinics, participants 

and WIC vendors in ways that are 

expected to increase equity and access 

for WIC participants during times of 

disaster. 

To mitigate potential impacts on 

Program access for LEP populations and 

persons with disabilities, FNS will 

provide WIC State agencies with 

technical assistance aimed at ensuring 

that communications about program 

changes are available in appropriate 

languages and in alternative formats for 

persons with disabilities. After 

reviewing the potential impacts, FNS 

does not believe the rule would result 

in civil rights impacts on protected 

groups of WIC participants and 

applicants. However, the FNS CRD will 

propose further outreach and mitigation 

strategies to alleviate any unforeseen 

impacts, if deemed necessary. 

Executive Order 13175 

Executive Order 13175 requires 

Federal agencies to consult and 

coordinate with Tribes on a 

government-to-government basis on 

policies that have Tribal implications, 

including regulations, legislative 

comments or proposed legislation, and 

other policy statements or actions that 

have substantial direct effects on one or 

more Indian Tribes, on the relationship 

between the Federal Government and 

Indian Tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

Tribal consultation regarding this rule 

was conducted on November 8, 2022. 

FNS provided an opportunity for 

consultation on the rule and Tribal 

leaders were generally supportive. If a 

Tribe requests consultation on this 

rulemaking in the future, FNS will work 

with USDA’s Office of Tribal Relations 

to ensure meaningful consultation is 

provided. 

Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. Chap. 35; 5 CFR part 1320) 

requires the Office of Management and 

Budget (OMB) approve all collections of 

information by a Federal agency before 

they can be implemented. Respondents 

are not required to respond to any 

collection of information unless it 

displays a current valid OMB control 

number. 

This final rule impacts existing 

information collection requirements that 

are contained in OMB Control Number 

0584–0043 Special Supplemental 

Nutrition Program for Women, Infants, 

and Children (WIC) Program 

Regulations—Reporting and 

Recordkeeping (expiration date 

December 31, 2023) which are subject to 

review and approval by OMB in 

accordance with the Paperwork 

Reduction Act of 1995. Additionally, 

the waiver elements of this rule are 

already in effect but codified in this rule 

and have been previously approved by 

OMB under OMB #0584–0687. Any 

further public comment on the waiver 

information collection solicited in 

response to this rule will be used to 

inform the next revision of the 

information collection. Therefore, FNS 

is submitting for public comment in this 

rule the changes in the information 

collection burdens in OMB Control 

Numbers 0584–0043 that would result 

from adoption of this rule. The 

information collection and 

recordkeeping requirements included in 

this final rule have been submitted by 

the Agency to OMB for approval which 

is currently pending. FNS will not 

collect any information associated with 

this rule until the information 

collections are approved by OMB. 

Comments on the information 

collection for this final rule must be 

received by February 12, 2024. 

Comments may be sent to: Allison 

Post, Food and Nutrition Service, U.S. 

Department of Agriculture, 1320 

Braddock Place, 3rd Floor, Alexandria, 

VA 22314. Comments will also be 

accepted through the Federal 

eRulemaking Portal. Go to http://

www.regulations.gov and follow the 

online instructions for submitting 

comments electronically. 

Comments are invited on: (a) whether 

the collection of information is 

necessary for the proper performance of 

the functions of the Department, 

including whether the information shall 

have practical utility; (b) the accuracy of 

the Department’s estimate of the burden 

of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

All responses to this notice will be 

summarized and included in the request 

for OMB approval. All comments will 

also become a matter of public record. 


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86560 Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 

a. Revisions to OMB Control Number 

0584–0043 

Title: Special Supplemental Nutrition 

Program for Women, Infants, and 

Children (WIC) Program Regulations— 

Reporting and Recordkeeping Burden. 

OMB Number: 0584–0043. 

Expiration Date: 12/31/2023. 

Type of Request: Revision of a 

currently approved collection. 

Abstract: This is a revision of existing 

information collection requirements in 

the information collection under OMB 

Control Number 0584–0043 that are 

affected by this rulemaking. Under this 

rule, the Department amends 7 CFR part 

246 to codify the provisions of ABFA 

and implement related changes which 

will strengthen WIC’s ability to address 

emergency periods and supply chain 

disruptions, particularly those 

impacting infant formula. This final rule 

impacts the burden associated with 

reporting and recordkeeping 

requirements for State agencies. This 

final rule may also result in additional 

financial costs to State agencies. 

(i) Burden Revisions Related to State 

Plan Requirements 

This rule requires WIC State agencies 

to include, as a part of the State Plan, 

a plan of alternate operating procedures, 

commonly referred to as a disaster plan 

in accordance with FNS guidance. 

Although current WIC regulations do 

not require WIC State agencies to 

develop and implement disaster plans, 

the Department has always encouraged 

WIC State agencies to develop them. 

While many WIC State agencies have a 

disaster plan, they are typically part of 

a broader health department or other 

State agency disaster plan and do not 

address WIC-specific Program 

operations during emergency periods 

and supply chain disruptions. 

FNS estimates that 82 WIC State 

agencies have a disaster plan, and that 

it will take these State agencies an 

additional 16 hours to update their 

existing disaster plans to conform with 

the added specific requirements for 

these plans included in this rulemaking. 

Of the remaining 7 WIC State agencies 

who do not have existing disaster plans, 

FNS estimates that it will take these 

State agencies 80 hours to develop 

disaster plans in accordance with this 

rulemaking. Therefore, FNS estimates 

that this rule would result in an increase 

of 21 burden hours to each State 

agency’s reporting burden ((82 State 

agencies × 16 hours) + (7 State agencies 

× 80 hours)/89 State agencies = 21 

burden hours). This would increase the 

burden hours to submit an annual State 

Plan from 134.62 to 155.62 which 

would increase the associated reporting 

burden by 1,869 burden hours. 

(ii) Burden Revision Related to Infant 

Formula Cost Containment Contracts 

Remedies 

This rule requires State agencies to 

include minimum required remedies in 

infant formula cost containment 

contracts to ensure that, in the event of 

an infant formula recall, any State 

agency for whom the Secretary has 

issued a waiver(s) under the conditions 

described in § 246.29 will be able to 

enact remedies to protect against 

disruption to Program participants. All 

State agencies must continuously 

operate a cost containment system for 

infant formula, with some exceptions. 

Notably, ITOs with 1,000 or fewer 

participants are exempt from this 

provision. As such, 79 State agencies 

out of 89 WIC State agencies have infant 

formula cost containment contracts. 

Contracts that State agencies entered 

into after ABFA was enacted on May 21, 

2022 may already include some of the 

requirements specified in this rule, as 

WIC Policy Memorandum #2022–6 

suggested remedies that are being 

codified in this rule. However, 

regardless of whether State agencies 

have included some of the remedies into 

their contracts, this rule includes greater 

specificity on the requirements outlined 

in WIC Policy Memorandum #2022–6 

and an additional requirement. 

Therefore, incorporating the rule’s 

minimum required remedies in infant 

formula cost containment contracts 

would require an estimated one-time 

two-hour burden per State agency. 

Therefore, FNS estimates that this rule 

would result in a one-time increase in 

148 burden hours to State agencies’ 

reporting burden (79 State agencies × 2 

burden hours = 148 burden hours). 

Additionally, this rule requires infant 

formula manufacturers to provide State 

agencies with an action plan to meet 

formula demand and limit disruption to 

Program participants in the affected 

jurisdiction(s) in the event of an infant 

formula recall. This plan must include 

current supply data to assist the State 

agency in their recall response. Based 

on the rarity of large-scale infant 

formula recalls, FNS estimates that one 

State agency and one infant formula 

manufacturer will be impacted by an 

infant formula recall each year, and that 

it will take the infant formula 

manufacturer 4 hours to provide the 

State agency with an action plan with 

current supply data. Therefore, FNS 

estimates that this rule would result in 

an additional 4 burden hours to 

businesses’ reporting burden (1 infant 

formula manufacturer × 4 burden hours 

= 4 burden hours). 

(iii) Burden Revisions Related to 

Emergency Period and Supply Chain 

Disruption Recordkeeping 

This rule requires State agencies 

establish a plan to report to FNS on 

alternate operating procedures 

implemented during an emergency 

period, supplemental food recall, and 

other supply chain disruptions, which 

includes Program data and information 

on the impact of benefit use and 

delivery. Additionally, this rule requires 

infant formula manufacturers to provide 

State agencies with an action plan to 

meet formula demand and limit 

disruption to program participants in 

the affected jurisdiction(s) in the event 

of an infant formula recall. This plan 

must include current supply data to 

assist the State agency in their recall 

response. FNS estimates that 15 State 

agencies will implement alternate 

operating procedures in the event of an 

emergency period or supply chain 

disruption, including an infant formula 

recall, each year. FNS estimates that it 

will take State agencies 2 hours to 

record data related to alternate operating 

procedures implemented during an 

emergency period or supply chain 

disruption, and supply data from infant 

formula manufacturers in the event of 

an infant formula recall. Therefore, FNS 

estimates that this rule would result in 

an additional 30 burden hours to State 

agencies’ recordkeeping burden (15 

State agencies × 2 burden hours = 30 

burden hours). 

Respondents: State agencies, 

including Indian Tribal Organizations 

and U.S. Territories (note that burden 

estimates for local agencies are not 

affected by this rule). 

Estimated Number of Respondents: 

90. 

Estimated Number of Responses per 

Respondent: 1.99. 

Estimated Total Annual Burden on 

Respondents: 14,032. 


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APPENDIX I—WIC BURDEN TABLE

Regulatory section Information collected 

Estimated 

number of 

respondents 

Annual 

responses 

per 

respondent 

Total 

annual 

responses 

Number of 

burden 

hours 

per request 

Estimated 

total 

burden 

hours 

Previous 

submission 

total hours 

per person 

Difference 

due to 

program 

changes 

REPORTING BURDEN ESTIMATES 

Affected Public: State and 

Local Agencies (including Indian Tribal Organizations and U.S. Territories) 

246.4 ....................................... State Plan ................................ 89 1 89 155.62 13,850.18 11,981.18 1,869.00 

246.16a(j) ................................ Infant formula cost containment contracts remedies.74 1 74 2 148 0 * 148 

Subtotal Reporting: State 

and Local Agencies.

.................................................. 89 2 163 85.88 13,998 11,981 2,017.00 

Affected Public: Business: Retail Vendors (WIC-Authorized Food Stores) 

246.16a(j) ................................ Infant formula contractor action plan.1 1 1 4 4 0 4 

Subtotal Reporting: Retail 

Vendors *.

1 .............................................. 1.00 1 4.00 4 0 4 

Grand Subtotal: Reporting.90 ............................................ 1.82 164 85.38 14,002 11,981 2,021 

RECORDKEEPING BURDEN ESTIMATES 

Affected Public: State and Local Agencies (including Indian Tribal Organizations and U.S. Territories) 

246.4(a)(30); 246.16a(j) .......... Emergency Period and Supply 

Chain Disruption Recordkeeping.

15 1 15 2 30 0 30 

Subtotal: Recordkeeping .. .................................................. 15 1.00 15 2.00 30 0 30 

Grand Total: Reporting and Recordkeeping................................................... 90 1.99 179 78.39 14,032 11,981 2,051 

* There is a one-time information collection burden associated with this provision. 

Summary of Requested Burden 

Revisions: 

TABLE 4—SUMMARY OF REQUESTED BURDEN REVISIONS TO #0584–0043 

Responses Respondents Time burden 

Current Inventory: * Total Burden ............................................................................................... 48,798,800 6,913,189 4,547,099 

Current Inventory: * Reporting ............................................................................................. 21,254,756 6,913,189 4,017,132 

Current Inventory: * Recordkeeping ..................................................................................... 27,544,044 11,897 529,967 

Total Burden Revision Requested ............................................................................................... 48,798,890 6,913,190 4,549,150 

Burden Revision Requested: Reporting ............................................................................... 21,254,831 6,913,190 4,019,153 

Burden Revision Requested: Recordkeeping ...................................................................... 11,897 27,544,059 529,997 

Difference in Total Burden from Rulemaking ................................................................ 90 1 2,051 

E-Government Act Compliance 

The Department is committed to 

complying with the E-Government Act, 

to promote the use of the internet and 

other information technologies to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. 

List of Subjects in 7 CFR Part 246 

Administrative practice and 

procedure, Civil rights, Food assistance 

programs, Grant programs—health, 

Grant programs—social programs, 

Indians, Infants and children, Maternal 

and child health, Nutrition, Penalties, 

Reporting and recordkeeping 

requirements, Women. 

Accordingly, the Department amends 

7 CFR part 246 as follows: 

PART 246—SPECIAL SUPPLEMENTAL 

NUTRITION PROGRAM FOR WOMEN, 

INFANTS AND CHILDREN 

■ 1. The authority citation for part 246 

continues to read as follows: 

Authority: 42 U.S.C. 1786. 

■ 2. Amend § 246.2 by adding the 

definitions for ‘‘Emergency period,’’ 

‘‘Qualified administration requirement,’’ 

‘‘Recall’’ and, ‘‘Supply Chain 


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86562 Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 

Disruption’’ in alphabetical order to 

read as follows: 

§ 246.2 Definitions. 

* * * * * 

Emergency period means a period 

during which there exists: 

(1) A presidentially declared major 

disaster as defined under section 102 of 

the Robert T. Stafford Disaster Relief 

and Emergency Assistance Act (42 

U.S.C. 5121 et seq.). 

(2) A presidentially declared 

emergency as defined under section 102 

of the Robert T. Stafford Disaster Relief 

and Emergency Assistance Act (42 

U.S.C. 5121 et seq.). 

(3) A public health emergency 

declared by the Secretary of HHS under 

section 319 of the Public Health Service 

Act (42 U.S.C. 247d). 

(4) A renewal of such a public health 

emergency pursuant to section 319. 

* * * * * 

Qualified administrative requirement 

means a statutory requirement under 

Section 17 of the Child Nutrition Act of 

1966 (CNA; 42 U.S.C. 1786) or a 

regulatory requirement issued pursuant 

to this section. 

* * * * * 

Recall means recall as defined in 21 

CFR 7.3(g) or any successor regulation. 

Recalls may be conducted voluntarily 

by a manufacturer or may be required by 

FDA. 

* * * * * 

Supply chain disruption means a 

shortage of WIC supplemental foods that 

limits WIC participants’ ability 

reasonably to purchase supplemental 

foods using WIC benefits within a State 

agency’s jurisdiction, as determined, 

and declared by the Secretary for the 

purposes of WIC. 

* * * * * 

■ 3. Amend § 246.4 by adding paragraph 

(a)(30) to read as follows: 

§ 246.4 State plan. 

(a) * * * 

(30) Plans of alternate operating 

procedures, commonly referred to as 

disaster plans, to support the 

continuation of WIC services during an 

emergency period as defined at § 246.2, 

supply chain disruption as defined at 

§ 246.2, and supplemental food recall. 

State agencies must consider the unique 

and sudden nature of an emergency 

period, supplemental food recall, and 

other supply chain disruptions when 

developing alternate operating 

procedures. Alternate procedures must 

describe the process by which the State 

agency will minimize the negative 

impact to WIC operations and services 

and ensure the availability of authorized 

supplemental foods, especially infant 

formula, to the extent feasible. At a 

minimum, alternate operating 

procedures must include- 

(i) A plan to address operation of 

specific Program areas including- 

(A) Access to Program records; 

(B) Alternate certification and benefit 

issuance 

(C) Verification of Certification (VOC) 

issuance 

(D) Food package adjustments; 

(E) Vendor requirements; 

(F) Benefit redemption; and 

(G) Food delivery systems. 

(ii) A plan to ensure continuity of 

WIC services and address the needs of 

participants with documented 

qualifying conditions receiving Food 

Package III, rural areas, Indian tribal 

organizations, and other priority 

populations in the affected area as 

applicable; 

(iii) A designated emergency contact 

within the State agency for emergency 

periods, supplemental food recalls, and 

other supply chain disruptions; 

(iv) A designated emergency contact 

within the State agency to address the 

needs of participants with documented 

qualifying conditions receiving Food 

Package III; 

(v) A plan to establish relationships 

with relief agencies responsible for 

disaster and public health emergency 

planning applicable to the State 

agency’s jurisdiction and participants to 

support data-informed approaches when 

responding to emergency periods, 

supplemental food recalls, and other 

supply chain disruptions; 

(vi) A plan to limit the disruption of 

infant formula benefits in the event of 

an emergency period, supplemental 

food recall, and other supply chain 

disruptions; 

(vii) A communications plan to keep 

FNS, State and local agency staff, 

authorized WIC vendors, WIC 

participants, and the public informed 

during an emergency period 

supplemental food recall, and other 

supply chain disruptions; 

(viii) A plan to report to FNS on 

alternate operating procedures 

implemented during an emergency 

period, supplemental food recall, and 

other supply chain disruptions which 

includes Program data and information 

on the impact of benefit use and 

delivery; and 

(ix) A plan to adjust State agency 

specific minimum requirements for the 

variety and quantity of supplemental 

foods that a vendor applicant must stock 

to be authorized. 

* * * * * 

■ 4. In § 246.16a: 

■ a. Revise paragraph (c)(5); and 

■ b. Add a new paragraph (n). 

The revision and addition read as 

follows: 

§ 246.16a Infant formula and authorized 

foods cost containment. 

* * * * * 

(c) * * * 

(5) A State agency must award the 

contract(s) to the responsive bidder(s) 

offering the lowest total monthly net 

price for infant formula or the highest 

monthly rebate (subject to 

paragraph(c)(4)(ii) of this section) for a 

standardized number of units of infant 

formula. To be responsive, a bidder 

must submit a bid by the deadline set 

by the State agency that conforms to the 

solicitation and must meet requirements 

at 246.16a and set forth in the bid 

solicitation. The State agency must 

calculate the lowest net price using the 

lowest national wholesale cost per unit 

for a full truckload of the infant formula 

on the date of the bid opening. 

* * * * * 

(n) What minimum recall-related 

provisions must be included in infant 

formula cost containment contracts? A 

State agency must include remedies in 

the event of a recall in their infant 

formula cost containment contract to 

protect against disruption in infant 

formula supply to participants. The 

State agency will determine when 

remedies take effect and remain in 

effect, in accordance with applicable 

Program requirements and the infant 

formula cost containment contract. At 

minimum, recall remedies in the State 

agency’s infant formula cost 

containment contract must: 

(1) Allow infant formula to be issued 

in all unit sizes that may exceed the 

maximum monthly allowance. The State 

agency and contracted infant formula 

manufacturer must prioritize unit sizes 

that most closely provide the maximum 

monthly allowance; 

(2) Allow the issuance of non-contract 

brand infant formulas without medical 

documentation, with the exception of 

participants receiving Food Package III 

as defined in section 246.10(e)(3) of this 

Part; and 

(3) When any contract brand infant 

formula of the contracted manufacturer 

is the subject of a recall, require the 

contracted infant formula manufacturer 

to: 

(i) Provide the State agency with an 

action plan, within a timeline 

established within the contract, which 

includes supply data, to meet infant 

formula demand and limit disruption to 

Program participants in the affected 

jurisdiction(s); and 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Rules and Regulations 86563 

1https://www.ecfr.gov/current/title-28/chapter-I/ 

part-42/subpart-F/section-42.406. 

(ii) Pay rebates on competitive, noncontract brand infant formula that meets 

the definition of infant formula at 7 CFR 

246.2. 

■ 5. Add § 246.29 to read as follows: 

§ 246.29 Waivers of program 

requirements. 

(a) Required conditions. The Secretary 

may waive or modify any qualified 

administrative requirement for one or 

more State agencies during an 

emergency period or supply chain 

disruption. Waivers or modifications 

may be issued following a State agency 

request or at the discretion of the 

Secretary. To be considered, a waiver or 

modification issued under this Section 

must meet the following requirements: 

(1) The qualified administrative 

requirement cannot be implemented 

during any part of the emergency period 

or supply chain disruption. 

(2) The waiver or modification is 

necessary to serve participants and does 

not substantially weaken the nutritional 

quality of supplemental foods. 

(3) The waiver or modification would 

not result in material impairment of any 

statutory or regulatory rights of 

participants or potential participants as 

set forth at 7 CFR 246.8 or 7 CFR parts 

15, 15a and 15b. 

(4) The waiver or modification would 

not create a barrier to participation. 

(5) The waiver or modification would 

not create additional eligibility 

requirements for participation. 

(6) The waiver or modification would 

comply with 7 CFR 246.13(b). 

(7) The waiver or modification must 

offer substitution options with similar 

nutritional quality, that most closely 

provide the maximum monthly 

allowance of supplemental foods, and 

that do not create new supplemental 

food categories as set forth in 7 CFR 

246.10(e)(12) Table 4. 

(8) A State agency that requests a 

waiver or modification meets additional 

requirements for the request and 

approval as determined necessary by 

FNS. 

(b) Timeframes for waiver request and 

use. (1) Waiver starts. A waiver or 

modification may be granted any time 

during an emergency period or supply 

chain disruption. 

(2) Waiver duration. 

(i) A waiver or modification 

established during an emergency period 

may be available for the emergency 

period and up to 60 days after the end 

of the emergency period. 

(ii) A waiver or modification 

established during a supply chain 

disruption may be available for: 

(A) a period of up to 45 days from the 

date of waiver issuance and renewed 

with at least 15 days’ notice provided by 

the Secretary; and 

(B) no more than 60 days after the 

supply chain disruption declaration 

ceases to exist. 

(c) State agency waiver requests. State 

agencies shall submit requests for a 

modification or waiver for USDA 

approval. Requests shall include but not 

necessarily be limited to: 

(1) The qualified administrative 

requirement the State agency is 

requesting to modify or waive 

(including the statutory or regulatory 

citation) and an explanation for why it 

cannot be met; 

(2) Justification for why the waiver is 

necessary to continue WIC services; 

(3) An explanation that the waiver 

meets the conditions set forth in 7 CFR 

246.29(a); 

(4) The emergency period or supply 

chain disruption under which the 

request is being made; 

(5) The period for which the 

flexibility is being requested. 

Cynthia Long, 

Administrator, Food and Nutrition Service. 

[FR Doc. 2023–26641 Filed 12–13–23; 8:45 am] 

BILLING CODE 3410–30–P 

DEPARTMENT OF AGRICULTURE 

Food and Nutrition Service 

7 CFR Part 272 

[FNS–2022–0005] 

RIN 0584–AE86 

Supplemental Nutrition Assistance 

Program: Revision of Civil Rights Data 

Collection Methods 

AGENCY: Food and Nutrition Service 

(FNS), Agriculture (USDA). 

ACTION: Final rule. 

SUMMARY: This rule finalizes provisions 

of a proposed rule published on June 27, 

2022. With this final rule, the Food and 

Nutrition Service (FNS) is revising 

Supplemental Nutrition Assistance 

Program (SNAP) regulations that cover 

collecting and reporting race and 

ethnicity data by State agencies on 

persons receiving benefits from SNAP. 

This rule removes regulatory language 

that provides an example that State 

agencies might collect race and 

ethnicity data by observation (also 

referred to as ‘‘visual observation’’) 

when participants do not voluntarily 

provide the information on the 

application form. In addition, based on 

feedback from the commenters, this rule 

prohibits using visual observation as a 

data collection method for race and 

ethnicity. Through this rulemaking, FNS 

intends to improve the quality of data 

collected for purposes of Federal civil 

rights law and policy including title VI 

of the Civil Rights Act of 1964. USDA’s 

Food and Nutrition Service is 

committed to promoting equity and 

inclusion through its Federal nutrition 

assistance programs. This regulatory 

change is consistent with this 

Administration’s priorities and furthers 

FNS’ commitment to building equitable 

and inclusive systems for nutrition 

access. 

DATES: This rule is effective February 

12, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Maribelle Balbes, Chief, State 

Administration Branch, Program 

Accountability and Administration 

Division, Supplemental Nutrition 

Assistance Program, Food and Nutrition 

Service, USDA, 1320 Braddock Place, 

5th Floor, Alexandria, VA 22314, by 

phone at (703) 605–4272 or via email at: 

SM.FN.SNAPSAB@usda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Current Policy 

Title VI of the Civil Rights Act of 1964 

prohibits discrimination on the basis of 

race, color, or national origin in 

programs receiving Federal financial 

assistance. Additionally, Department of 

Justice (DOJ) regulations at title 28 of 

the Code of Federal Regulations (CFR), 

§ 42.406(a),1 require all Federal agencies 

to provide guidelines for the collection 

of race and ethnicity data from 

applicants and beneficiaries of Federal 

assistance programs sufficient to permit 

effective enforcement of title VI. 

Accordingly, SNAP regulations at 7 CFR 

272.6(g) and (h) require State agencies to 

collect race and ethnicity data on 

participating households and report the 

data to FNS to help ensure program 

benefits are distributed without regard 

to race, color, or national origin. FNS 

uses this data to determine how 

effectively FNS programs are reaching 

potential eligible persons and 

beneficiaries, identify areas where 

additional outreach is needed, assist in 

the selection of locations for compliance 

reviews, and complete reports, as 

required. State agencies report aggregate 

race and ethnicity data to FNS annually 

via the form FNS–101, ‘‘Participation in 

Food Programs by Race’’ (Office of 

Management and Budget (OMB) Control 

Number 0584–0594, expiration 7/31/ 

2023). FNS uses this aggregate data to 

conduct compliance reviews and 


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